Methods for lifting skin tissue

ABSTRACT

Methods for treating skin and subcutaneous tissue with energy such as ultrasound energy are disclosed. In various embodiments, ultrasound energy is applied at a region of interest to affect tissue by cutting, ablating, micro-ablating, coagulating, or otherwise affecting the subcutaneous tissue to conduct numerous procedures that are traditionally done invasively in a non-invasive manner. Methods of lifting sagging tissue are described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/697,970, filed Nov. 27, 2019, issued as U.S. Pat. No. 11,400,319,which is a continuation of U.S. application Ser. No. 16/049,293, filedJul. 30, 2018, issued as U.S. Pat. No. 10,532,230, U.S. application Ser.No. 15/248,454, filed Aug. 26, 2016, issued as U.S. Pat. No. 10,046,182,which is a continuation of U.S. application Ser. No. 14/554,571 filedNov. 26, 2014, issued as U.S. Pat. No. 9,427,601, which is acontinuation of U.S. application Ser. No. 13/835,635 filed Mar. 15,2013, issued as U.S. Pat. No. 8,915,853, which is a continuation of U.S.application Ser. No. 13/494,856 filed Jun. 12, 2012, issued as U.S. Pat.No. 8,444,562, which is a continuation-in-part of U.S. application Ser.No. 11/857,989 filed Sep. 19, 2007, now abandoned, which claims thebenefit of priority from U.S. Provisional No. 60/826,199 filed Sep. 19,2006, each of which are incorporated in its entirety by reference,herein. U.S. application Ser. No. 13/494,856, issued as U.S. Pat. No.8,444,562, is also a continuation-in-part of U.S. application Ser. No.12/028,636 filed Feb. 8, 2008, issued as U.S. Pat. No. 8,535,228, whichis a continuation-in-part of U.S. application Ser. No. 11/163,151 filedon Oct. 6, 2005, now abandoned, which in turn claims priority to U.S.Provisional Application No. 60/616,755 filed on Oct. 6, 2004, each ofwhich are incorporated in its entirety by reference, herein. Further,U.S. application Ser. No. 12/028,636, issued as U.S. Pat. No. 8,535,228,is a continuation-in-part of U.S. application Ser. No. 11/163,148 filedon Oct. 6, 2005, now abandoned, which in turn claims priority to U.S.Provisional Application No. 60/616,754 filed on Oct. 6, 2004, each ofwhich are incorporated in its entirety by reference, herein. Any and allpriority claims identified in the Application Data Sheet, or anycorrection thereto, are hereby incorporated by reference under 37 CFR1.57.

FIELD OF INVENTION

Several embodiments of the present invention generally relate toultrasound treatment and imaging devices for use on any part of thebody, and more specifically relate to ultrasound devices having atransducer probe operable to emit and receive ultrasound energy forcosmetic and/or medical treatment and imaging.

BACKGROUND

Subcutaneous tissues such as muscles, tendons, ligaments and cartilageare important connective tissues that provide force and motion,non-voluntary motion, anchoring, stability, and support among otherfunctions. These tissues can cause changes to cosmetic and/or aestheticappearance, and are prone to wear and injury because of the naturalaging process, sports and other activities which put stress on thetissues.

Muscle tissue is capable of contraction and expansion. Skeletal muscleis a fibrous tissue used to generate stress and strain. For example,skeletal muscles in the forehead region can produce frowning andwrinkles. There are several muscles within the forehead region includingthe epicranius muscle, the corrugator supercilii muscle, and theprocerus muscle. These muscles are responsible for movement of theforehead and various facial expressions. Besides muscles, other tissuesexist in the forehead region that also can lead to wrinkles and othercosmetic/aesthetic effects on the forehead.

One popular procedure for reducing wrinkles on the forehead is acosmetic procedure known as a brow lift. During a brow lift, portions ofmuscle, fat, and other tissues in the forehead region are invasivelycut, removed, and/or paralyzed to reduce or eliminate wrinkles from theforehead. For example, traditional brow lifts require an incisionbeginning at one ear and continuing around the forehead at the hair lineto the other ear. Once the incision is made, various tissues (andportions of those tissues) such as muscles or fat are cut, removed,manipulated, or paralyzed to reduce wrinkles. For example, portions ofthe muscle that causes vertical frown lines between the brows can beremoved during a brow lift to reduce or eliminate wrinkles.

A less invasive brow lift procedure is known as an “endoscopic lift.”During an endoscopic brow lift, smaller incisions are made along theforehead and an endoscope and surgical cutting tools are inserted withinthe incisions to cut, remove, manipulate, or paralyze tissue to reduceor eliminate wrinkles from the brow.

Unfortunately, both traditional and endoscopic brow lifts are invasiveand require hospital stays.

There are certain treatments to remove or reduce the appearance ofwrinkles on the forehead that are less invasive. Such treatments aredesigned purely to paralyze muscles within the forehead. Paralyzing themuscle prevents it from moving and therefore, prevents wrinkles. Onesuch treatment is the injection of Botulin toxin, a neurotoxin soldunder the trademark BOTOX®., into muscle tissue to paralyze the tissue.However, such cosmetic therapy is temporary and requires chronic usageto sustain the intended effects. Further, BOTOX-type treatments maycause permanent paralysis and disfigurement. Finally, these types oftreatments are limited in the scope of treatment they provide.

Another area where subcutaneous tissue can be problematic is around theeyes. Specifically, excess fat embedded in the support structure aroundthe lower and upper eyelids can cause eyes to be puffy and give theappearance of fatigue. Moreover, “bags” of excess fat and skin caused byexcess fat and loose connective tissue typically form around a person'seyes as she ages. Generally, these problems associated with varioustissues around the eyes are cosmetic; however, in certain cases the skincan droop so far down that a patient's peripheral vision is affected.

Besides droopy skin, puffy eyelids, and bags around the eyes, wrinklescan appear that extend from the outer corner of the eye around the sideof a patient's face. These wrinkles are known as “crow's feet.” Crow'sfeet are caused in part by the muscle around the eye known as the“orbicularis oculi muscle.” Crow's feet can be treated by paralyzing orotherwise incapacitating the orbicularis oculi muscle.

Surgery to remove wrinkles, droopy skin, puffy eyelids, and bags aroundthe eyes is referred to as a “blepharoplasty.” During a blepharoplastyprocedure, a surgeon removes fat, muscle, or other tissues responsiblefor the natural effects of aging that appear near a patient's eyes. Ablepharoplasty can be limited to the upper eyelids (an “upper lidblepharoplasty”), the lower eyelids (a “lower lid blepharoplasty”) orboth the upper and lower eyelids.

During a traditional blepharoplasty, an incision is made along thenatural lines of a patient's eyelids. In an upper lid blepharoplasty, asurgeon will make the incisions along the creases of the patient's uppereyelids and during a lower lid blepharoplasty; incisions are made justbelow the patient's eyelashes. Once the incisions are made, the surgeonseparates skin from the underlying fatty tissue and muscle beforeremoving the excess fat and unneeded muscle.

Another type of blepharoplasty has developed which is known as a“transconjunctival blepharoplasty.” A transconjunctival blepharoplastytypically is only used to remove pockets of fat along the lower eyelids.During a transconjunctival blepharoplasty, three incisions are madealong the interior of the lower eyelid and fatty deposits are removed.

Blepharoplasty procedures can have many drawbacks. Most notably,traditional blepharoplasty procedures are fairly invasive and manypatients must spend a week or more recovering at home until the swellingand black and blue eyes disappear. Further, most patients who have had ablepharoplasty are irritated by wind for several months after theprocedure. Therefore, it would be desirable to provide a less invasiveblepharoplasty procedure to improve the appearance of the eye region.

A blepharoplasty procedure alone is typically not the best way to treatcrow's feet. Removing crow's feet after procedures to remove excess fat,skin, muscle, and other tissues around the eye is commonly requested bypatients to remove all the wrinkles around the eyes. Crow's feet aretypically treated by paralyzing the orbicularis oculi muscle with aninjection of Botulin toxin, a neurotoxin sold under the trademarkBOTOX®. However, such cosmetic therapy is temporary and requires chronicusage to sustain the intended effects. Further, BOTOX-type treatmentsmay cause permanent paralysis and disfigurement. In addition, the animalprotein-based formulation for BOTOX-type treatments makes patients moreprone to immune reactions. Therefore, it would also be desirable toprovide a method of treating the eyes that replaced not only ablepharoplasty, but also eliminated the need for BOTOX-type treatmentsto remove crow's feet.

Cartilage tissue is yet another subcutaneous tissue that can be treatedwith ultrasound. Cartilage tissue is thin, rubbery, elastic tissue thatcomprises numerous body parts and acts as a cushion along the joints.For example, the ears and nose contain cartilage tissue which gives theears and nose their elastic flexibility. Cartilage tissue also coversthe ends of bones in normal joints and acts as a natural shock absorberfor the joint and reduces friction between the two bones comprising thejoint.

Cartilage is also responsible for many of the complaints that peoplehave about their appearance, specifically their ears and nose. Forexample, many people complain that their ears stick outward from theirhead too much or that their ears are simply too big and dislike theappearance of their ears for these reasons. Patients can elect tocorrect this condition by cutting, removing, or reshaping the cartilageof the ears to re-shape the ears so they do not project as much from theperson's head or are smaller.

During ear surgery, cartilage is removed, cut, or sculpted to change theappearance of the ears. One type of ear surgery is known as an“otoplasty” wherein the cartilage within the ears is cut, removed, orotherwise sculpted to reduce the projections of the ears from the headand allow the ears to rest against the patient's head thereby reducingthe angle of the ear to the head. In a traditional otoplasty, a surgeonmakes an incision in the back of the ear to expose the ear cartilage.Once the incision is made, the surgeon may sculpt or remove thecartilage. In certain cases, large pieces of cartilage are removedduring surgery to change the shape and appearance of the ears. Stitchesare used to close the incision made during surgery and to help maintainthe new shape of the patient's ears.

While effective, traditional ear surgeries such as an otoplasty takeseveral hours and require an overnight hospital stay for the mostaggressive procedures. Further, the cartilage can become infected duringthe surgery and blood clots can form within the ear that must be drawnout if not dissolved naturally. Other problems associated with earsurgery include a recovery period that lasts several days and requirespatients to wear bandages around their ears which are uncomfortable.

Further complicating matters is that many patients undergoing earsurgery such as an otoplasty are children between the ages of four tofourteen. The complications noted above that result from traditionalsurgeries are only magnified in patients this young. It would thereforebe desirable to have a method of treating cartilage that is non-invasiveto alleviate the disadvantages of a traditional invasive ear surgeries.

Coarse sagging of the skin and facial musculature occurs gradually overtime due to gravity and chronic changes in connective tissue generallyassociated with aging. Invasive surgical treatment to tighten suchtissues is common, for example by facelift procedures. In thesetreatments for connective tissue sagging, a portion of the tissue isusually removed, and sutures or other fasteners are used to suspend thesagging tissue structures. On the face, the Superficial MuscularAponeurosis System (SMAS) forms a continuous layer superficial to themuscles of facial expression and beneath the skin and subcutaneous fat.Conventional face lift operations involve suspension of the SMAS throughsuch suture and fastener procedures.

It is an object of some embodiments of the present invention to providethe combination of targeted, precise, local heating to a specifiedtemperature region capable of inducing coagulation and/or ablation(thermal injury) to underlying skin and subcutaneous fat. Attempts haveincluded the use of radio frequency (RF) devices that have been used toproduce heating and shrinkage of skin on the face with some limitedsuccess as a non-invasive alternative to surgical lifting procedures.However, RF is a dispersive form of energy deposition. RF energy isimpossible to control precisely within the heated tissue volume anddepth, because resistive heating of tissues by RF energy occurs alongthe entire path of electrical conduction through tissues. Anotherrestriction of RF energy for non-invasive tightening of the SMAS isunwanted destruction of the overlying fat and skin layers. The electricimpedance to RF within fat, overlying the suspensory connectivestructures intended for shrinking, leads to higher temperatures in thefat than in the target suspensory structures. Similarly, mid-infraredlasers and other light sources have been used to non-invasively heat andshrink connective tissues of the dermis, again with limited success.However, light is not capable of non-invasive treatment of SMAS becauselight does not penetrate deeply enough to produce local heating there.Below a depth of approximately 1 mm, light energy is multiply scatteredand cannot be focused to achieve precise local heating.

SUMMARY

Methods and systems for ultrasound treatment of tissue are provided. Inan embodiment, tissue such as muscle, tendon, fat, ligaments andcartilage are treated with ultrasound energy. The ultrasound energy canbe focused, unfocused or defocused and is applied to a region ofinterest containing at least one of muscle, tendon, ligament orcartilage (MTLC) tissue to achieve a therapeutic effect.

In certain embodiments, various procedures that are traditionallyperformed through invasive techniques are accomplished by targetingenergy such as ultrasound energy at specific subcutaneous tissues.Certain procedures include a brow lift, a blepharoplasty, and treatmentof cartilage tissue.

In one embodiment, a method and system for non-invasively treatingsubcutaneous tissues to perform a brow lift is provided. In anembodiment, a non-invasive brow lift is performed by applying ultrasoundenergy at specific depths along the brow to ablatively cut, cause tissueto be reabsorbed into the body, coagulate, remove, manipulate, orparalyze subcutaneous tissue such as the corrugator supercilii muscle,the epicranius muscle, and the procerus muscle within the brow to reducewrinkles.

In one embodiment, ultrasound energy is applied at a region of interestalong the patient's forehead. The ultrasound energy is applied atspecific depths and is capable of targeting certain subcutaneous tissueswithin the brow such as muscles and fat. The ultrasound energy targetsthese tissues and cuts, ablates, coagulates, micro-ablates, manipulates,or causes the subcutaneous tissue to be reabsorbed into the patient'sbody which effectuates a brow lift non-invasively.

For example, in one embodiment, the corrugator supercilii muscle on thepatient's forehead can be targeted and treated by the application ofultrasound energy at specific depths. This muscle or other subcutaneousmuscles can be ablated, coagulated, micro-ablated, shaped or otherwisemanipulated by the application of ultrasound energy in a non-invasivemanner. Specifically, instead of cutting a corrugator supercilii muscleduring a classic or endoscopic brow lift, the targeted muscle such asthe corrugator supercilii can be ablated, micro-ablated, or coagulatedby applying ultrasound energy at the forehead without the need fortraditional invasive techniques.

Various embodiments of methods and systems are configured for targetedtreatment of subcutaneous tissue in the forehead region in variousmanners such as through the use of therapy only, therapy and monitoring,imaging and therapy, or therapy, imaging and monitoring. Targetedtherapy of tissue can be provided through ultrasound energy delivered atdesired depths and locations via various spatial and temporal energysettings. In one embodiment, the tissues of interest are viewed inmotion in real time by utilizing ultrasound imaging to clearly view themoving tissue to aid in targeting and treatment of a region of intereston the patient's forehead. Therefore, the physician performing thenon-invasive brow lift can visually observe the movement and changesoccurring to the subcutaneous tissue during treatment.

In another embodiment, a method and system for performing a non-invasiveblepharoplasty by treating various tissues with energy is provided. Inan embodiment, a non-invasive blepharoplasty that can effectively treatcrow's feet is performed by applying ultrasound energy at specificdepths around the patient's eyes to ablate, cut, manipulate, caused tobe reabsorbed into the body, and/or paralyze tissue around the eyes toreduce wrinkles including crow's feet, puffiness, and/or sagging skin.

In one embodiment, ultrasound energy is applied at a region of interestaround the patient's eyes. The ultrasound energy is applied at specificdepths and is capable of targeting certain tissues including varioussubcutaneous tissues. For example, pockets of fat near the patient'seyelids can be targeted and treated by the application of ultrasoundenergy at specific depths. These pockets of fat can be ablated andreabsorbed into the body during the treatment. Muscles, skin, or othersupporting, connective tissues can be ablated, shaped, or otherwisemanipulated by the application of ultrasound energy in a non-invasivemanner. Specifically, instead of cutting into the sensitive area aroundthe patient's eyes as is done during a traditional blepharoplasty ortransconjunctival blepharoplasty, the targeted tissues can be treated byapplying ultrasound energy around the eyes without the need fortraditional invasive techniques.

Further, by applying energy at a region of interest that is partiallycomprised by the orbicularis oculi muscle, the energy can be used toparalyze or otherwise selectively incapacitate or modify thisorbicularis oculi muscle tissue. Therefore, the need for redundantBOTOX-type injections is eliminated and the entire eye region can betreated in this non-invasive manner.

In various embodiments, a method and system are configured for targetedtreatment of tissue around the eyes in various manners such as throughthe use of therapy only, therapy and monitoring, imaging and therapy, ortherapy, imaging and monitoring. Targeted therapy of tissue can beprovided through ultrasound energy delivered at desired depths andlocations via various spatial and temporal energy settings.

In another embodiment, the tissues of interest are viewed in motion inreal time by utilizing ultrasound imaging to clearly view the movingtissue to aid in targeting and treatment of a region of interest nearthe patient's eyes. Therefore, the physician performing the non-invasiveblepharoplasty can visually observe the movement and changes occurringto the tissue during treatment.

In yet another embodiment, a method and system for treating variouscartilage tissues with energy is provided. In an embodiment, anon-invasive otoplasty is performed by applying ultrasound energy atspecific depths along the pinna of the ear to ablatively cut, causetissue to be reabsorbed into the body, or manipulate cartilage tissuewithin the ear to reduce the angle at which the ears protrude from thehead.

In one embodiment, ultrasound energy is targeted to a region of interestalong the pinna of the patient's ear. The ultrasound energy is appliedat specific depths and is capable of targeting cartilage tissue withinthe ear such as scapha cartilage and scaphoid fossa which in part, formthe pinna of the ear. The ablative cutting, shaping, and manipulating ofcartilage can be used to reduce the overall size of the patient's ear orbe used to ablate the tissue and cause it to be reabsorbed into the bodyto perform a non-invasive otoplasty thereby allowing the ears to restagainst the head.

In other embodiments, cartilage tissue at other locations of thepatient's body can be treated according to the method and system of thepresent invention. In one such embodiment, nose surgery or a“rhinoplasty” can be performed using targeted ultrasound energy. Duringa rhinoplasty procedure, energy is applied at specific depths and iscapable of targeting cartilage within the nose. The cartilage can beablatively cut, shaped or otherwise manipulated by the application ofultrasound energy in a non-invasive manner. This cutting, shaping, andmanipulating of the cartilage of the nose can be used to cause thecartilage to be reabsorbed into the body, ablate, or coagulate thecartilage of the nose to perform a non-invasive rhinoplasty according tothe present invention.

In various embodiments, a method and system are configured for targetedtreatment of cartilage tissue in various manners such as through the useof therapy only, therapy and monitoring, imaging and therapy, ortherapy, imaging and monitoring. Targeted therapy of tissue can beprovided through ultrasound energy delivered at desired depths andlocations via various spatial and temporal energy settings. In oneembodiment, the cartilage is viewed in motion in real time by utilizingultrasound imaging to clearly view the cartilage to aid in targeting andtreatment of a region of interest. Therefore, the physician or otheruser can visually observe the movement and changes occurring to thecartilage during treatment.

In any of the embodiments disclosed herein, one or more of the followingeffects is achieved: a face lift, a brow lift, a chin lift, a wrinklereduction, a scar reduction, a tattoo removal, a vein removal, sun spotremoval, and acne treatment. In various embodiments, the treatmentfunction is one of face lift, a brow lift, a chin lift, an eyetreatment, a wrinkle reduction, a scar reduction, a burn treatment, atattoo removal, a vein removal, a vein reduction, a treatment on a sweatgland, a treatment of hyperhidrosis, sun spot removal, an acnetreatment, and a pimple removal. In another embodiment, the device maybe used on adipose tissue (e.g., fat).

In any of the embodiments disclosed herein, imaging occurs prior to thetherapy, simultaneously with the therapy, or after the therapy. Inseveral of the embodiments described herein, the procedure is entirelycosmetic and not a medical act.

In one embodiment, a method of treating sagging brows includesacoustically coupling an ultrasound probe system to a skin surface on abrow. In one embodiment, the ultrasound probe system includes an imagingelement, a therapy element, and a motion mechanism. The motion mechanismis controlled by a control system in communication with the ultrasoundprobe. The method can include using the ultrasound imaging element toimage a region of interest under the skin surface at a fixed depth, theregion of interest comprising a tissue comprising a portion of at leastone of muscular fascia, fat, and SMAS tissue. In one embodiment, theregion of interest at the fixed depth is displayed on a display system,the display system being electronically connected to the ultrasoundimaging element. The method includes using the ultrasound therapyelement to treat the region of interest. The therapy element is coupledto the motion mechanism within the probe. The therapy element isconfigured for targeted delivery of ablative ultrasound energy to form athermal lesion with at least a temperature sufficient to treat at leasta portion of the tissue at the fixed depth of up to about 9 mm from theskin surface. The method can include activating the motion mechanismwithin the probe to form a plurality of the thermal lesions along a lineat the fixed depth into the tissue to cause any one of the groupconsisting of ablation, deactivation, and shrinkage of at least aportion of the tissue. In one embodiment, the plurality of thermallesions facilitates a tightening of the tissue that leads to a browlift.

In one embodiment, the imaging element is configured to image with animaging frequency of between 2 kHz to 75 MHz and the therapy element isconfigured to treat with a treatment frequency of between 4 MHz and 15MHz. In one embodiment, the fixed depth of the lesion is within a rangeof 0 to 5 mm from the skin surface. In one embodiment, the fixed depthof the lesion is within a range of 1 mm to 6 mm from the skin surface.In one embodiment, the activating of the motion mechanism includescommunication between and at least two of the group consisting of acontrol system, an accelerometer, encoder and a position/orientationdevice.

In one embodiment, a method of treating skin on a face includesproviding a probe that emits ultrasound energy, coupling the probe to askin surface on the face proximate a region comprising subcutaneous fat,muscle, and connective tissue. The method can include emitting anddirecting ultrasound energy from the probe to specific depths to targetthe subcutaneous fat, muscle, and connective tissue. In one embodiment,the method includes applying a sufficient amount of ultrasound energy tocoagulate at least one of subcutaneous fat, muscle, and connectivetissue. In one embodiment, the method includes coagulating a sufficientamount of the subcutaneous fat, muscle, and connective tissue to reduceskin sagging on the face.

In one embodiment, a sufficient amount of ultrasound energy is emittedto ablate the subcutaneous fat, muscle, and connective tissueresponsible for wrinkles. In one embodiment, the subcutaneous fat tissueis disposed along the lower eyelid and a lower lid blepharoplasty isperformed. In one embodiment, the subcutaneous fat tissue is disposedalong the upper eyelid and an upper lid blepharoplasty is performed. Inone embodiment, the subcutaneous fat tissue is disposed along both theupper and lower eyelids and both an upper and lower blepharoplasty isperformed. In one embodiment, the region is located near an eye regionfurther includes the orbicularis oculi muscle. In one embodiment, theapplication of ultrasound energy ablates the orbicularis oculi muscle.In one embodiment, the ablation of the orbicularis oculi muscle resultsin the removal of crow's feet. In one embodiment, the region includes acorrugator supercilii muscle. In one embodiment, the corrugatorsupercilii muscle is ablated with ultrasound energy at a frequency of3-7 MHz.

In one embodiment, a method of reducing wrinkles on a brow with acombined imaging and therapy ultrasound transducer includes identifyinga treatment area comprising at least one wrinkle in a skin surface andwrinkle causing subcutaneous tissue. In one embodiment, the methodincludes imaging at least a portion of the treatment area with anultrasound transducer configured for both imaging and therapy. In oneembodiment, the method includes delivering ultrasound energy with theultrasound transducer through the skin surface and into a portion of thetreatment area comprising the wrinkle-causing subcutaneous tissue tocause thermally injury to a portion of the wrinkle-causing subcutaneoustissue, thereby reducing the at least one wrinkle the skin surface.

In one embodiment, delivering ultrasound energy is in a frequency rangeof about 2 MHz to about 25 MHz. In one embodiment, delivering ultrasoundenergy is at an energy level sufficient to cause the portion of thewrinkle-causing subcutaneous tissue to reabsorb into the body. In oneembodiment, the portion of the wrinkle-causing subcutaneous tissueincludes a portion of an epicranius muscle. In one embodiment, theportion of the wrinkle-causing subcutaneous tissue includes a portion ofa procerus muscle.

Further areas of applicability will become apparent from the descriptionprovided herein. It should be understood that the description andspecific examples are intended for purposes of illustration only and arenot intended to limit the scope of the embodiments disclosed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter of various embodiments of the invention isparticularly pointed out in the concluding portion of the specification.Embodiments of the invention, however, both as to organization andmethod of operation, may be better understood by reference to thefollowing description taken in conjunction with the accompanying drawingfigures, in which like parts may be referred to by like numerals. Thedrawings described herein are for illustration purposes only and are notintended to limit the scope of the present disclosure in any way.Embodiments of the present invention will become more fully understoodfrom the detailed description and the accompanying drawings wherein:

FIG. 1 illustrates a flow chart of the treatment method for performing abrow lift in accordance with an embodiment of the present invention;

FIG. 2 illustrates a patient's head and the location of the muscles thatcan be treated during a brow lift in accordance with embodiments of thepresent invention;

FIG. 3 illustrates a schematic diagram of an ultrasound treatment systemconfigured to treat subcutaneous tissue during a brow lift in accordancewith an embodiment of the present invention;

FIG. 4 illustrates various layers of subcutaneous tissue that the can betreated or imaged during a brow lift in accordance with an embodiment ofthe present invention;

FIG. 5 illustrates a layer of muscle tissue being treated during a browlift in accordance with an embodiment of the present invention;

FIG. 6 illustrates a block diagram of a treatment system for performinga brow lift in accordance with an embodiment of the present invention;

FIGS. 7A, 7B, 7C, 7D, and 7E illustrate cross-sectional diagrams of antransducer used in a system used to effectuate a brow lift in accordancewith various embodiments of the present invention;

FIGS. 8A, 8B, and 8C illustrate block diagrams of an control system usedin a system for effectuating a brow lift in accordance with embodimentsof the present invention;

FIG. 9 illustrates a flow chart of the treatment method for performing ablepharoplasty in accordance with an embodiment of the presentinvention;

FIGS. 10A and 10B illustrate a patient's head and the location of thetissues that can be treated during a blepharoplasty in accordance withembodiments of the present invention;

FIG. 11 illustrates a schematic diagram of an ultrasound treatmentsystem configured to treat tissue during a blepharoplasty in accordancewith an embodiment of the present invention;

FIG. 12 illustrates a schematic diagram of an ultrasound treatmentsystem configured to treat subcutaneous tissue during a blepharoplastyin accordance with an embodiment of the present invention;

FIG. 13 illustrates various layers of tissue that the can be treated orimaged during a blepharoplasty in accordance with embodiments of thepresent invention;

FIG. 14 illustrates a layer of muscle or other relevant tissue beingtreated during a blepharoplasty in accordance with an embodiment of thepresent invention;

FIGS. 15A, 15B, 15C, 15D, and 15E illustrate cross-sectional diagrams ofan transducer used in a system used to effectuate a blepharoplasty inaccordance with various embodiments of the present invention; and

FIGS. 16A, 16B, and 16C illustrate block diagrams of an control systemused in a system used to effectuate a blepharoplasty in accordance withembodiments of the present invention;

FIG. 17 illustrates a flow chart of the treatment method for treatingcartilage in accordance with an embodiment of the present invention;

FIG. 18 illustrates a patient's head and the location of the cartilagethat can be treated in accordance with embodiments of the presentinvention;

FIG. 19 illustrates a schematic diagram of a treatment system configuredto treat cartilage tissue in accordance with an embodiment of thepresent invention;

FIG. 20 illustrates various layers of tissue and cartilage tissue thatthe can be treated or imaged in accordance with an embodiment of thepresent invention;

FIG. 21 illustrates a layer of cartilage tissue being treated inaccordance with an embodiment of the present invention;

FIG. 22 illustrates a block diagram of a treatment system used to treatcartilage in accordance with an embodiment of the present invention;

FIGS. 23A, 23B, 23C, 23D, and 23E illustrate cross-sectional diagrams ofan transducer used in a system used to treat cartilage in accordancewith various embodiments of the present invention; and

FIGS. 24A, 24B and 24C illustrate block diagrams of an control systemused in a system used to treat cartilage in accordance with embodimentsof the present invention.

FIG. 25 illustrates a block diagram of a treatment system in accordancewith an embodiment of the present invention;

FIGS. 26A-26F illustrates schematic diagrams of an ultrasoundimaging/therapy and monitoring system for treating the SMAS layer inaccordance with various embodiments of the present invention;

FIGS. 27A and 27B illustrate block diagrams of a control system inaccordance with embodiments of the present invention;

FIGS. 28A and 28B illustrate block diagrams of a probe system inaccordance with embodiments of the present invention;

FIG. 29 illustrates a cross-sectional diagram of a transducer inaccordance with an embodiment of the present invention;

FIGS. 30A and 30B illustrate cross-sectional diagrams of a transducer inaccordance with embodiments of the present invention;

FIG. 31 illustrates transducer configurations for ultrasound treatmentin accordance with various embodiments of the present invention;

FIGS. 32A and 32B illustrate cross-sectional diagrams of a transducer inaccordance with another embodiment of the present invention;

FIG. 33 illustrates a transducer configured as a two-dimensional arrayfor ultrasound treatment in accordance with an embodiment of the presentinvention;

FIGS. 34A-34F illustrate cross-sectional diagrams of transducers inaccordance with other embodiments of the present invention;

FIG. 35 illustrates a schematic diagram of an acoustic coupling andcooling system in accordance with an embodiment of the presentinvention;

FIG. 36 illustrates a block diagram of a treatment system comprising anultrasound treatment subsystem combined with additional subsystems andmethods of treatment monitoring and/or treatment imaging as well as asecondary treatment subsystem in accordance with an embodiment of thepresent invention;

FIG. 37 illustrates a schematic diagram with imaging, therapy, ormonitoring being provided with one or more active or passive oralinserts in accordance with an embodiment of the present invention;

FIG. 38 illustrates a cross sectional diagram of a human superficialtissue region of interest including a plurality of lesions of controlledthermal injury in accordance with an embodiment of the presentinvention;

FIG. 39 illustrates a diagram of simulation results for variousspatially controlled configurations in accordance with embodiments ofthe present invention;

FIG. 40 illustrates an diagram of simulation results of a pair oflesioning and simulation results in accordance with the presentinvention; and

FIG. 41 illustrates another diagram of simulation results of a pair oflesioning results in accordance with the present invention.

DETAILED DESCRIPTION

The following description sets forth examples of embodiments, and is notintended to limit the present invention(s) or its teachings,applications, or uses thereof. It should be understood that throughoutthe drawings, corresponding reference numerals indicate like orcorresponding parts and features. The description of specific examplesindicated in various embodiments of the present invention are intendedfor purposes of illustration only and are not intended to limit thescope of the invention disclosed herein. Moreover, recitation ofmultiple embodiments having stated features is not intended to excludeother embodiments having additional features or other embodimentsincorporating different combinations of the stated features. Further,features in one embodiment (such as in one figure) may be combined withdescriptions (and figures) of other embodiments.

In one embodiment, methods and systems for ultrasound treatment oftissue are configured to provide cosmetic treatment. In variousembodiments of the present invention, tissue below or even at a skinsurface such as epidermis, dermis, fascia, and superficial muscularaponeurotic system (“SMAS”), are treated non-invasively with ultrasoundenergy. The ultrasound energy can be focused, unfocused or defocused andapplied to a region of interest containing at least one of epidermis,dermis, hypodermis, fascia, and SMAS to achieve a therapeutic effect. Inone embodiment, the present invention provides non-invasivedermatological treatment to produce eyebrow lift through tissuecoagulation and tightening. In one embodiment, the present inventionprovides imaging of skin and sub-dermal tissue. Ultrasound energy can befocused, unfocused or defocused, and applied to any desired region ofinterest, including adipose tissue. In one embodiment, adipose tissue isspecifically targeted.

In various embodiments, certain cosmetic procedures that aretraditionally performed through invasive techniques are accomplished bytargeting energy, such as ultrasound energy, at specific subcutaneoustissues. In several embodiments, methods and systems for non-invasivelytreating subcutaneous tissues to perform a brow lift are provided;however, various other cosmetic treatment applications, such as facelifts, acne treatment and/or any other cosmetic treatment application,can also be performed with the cosmetic treatment system. In oneembodiment, a system integrates the capabilities of high resolutionultrasound imaging with that of ultrasound therapy, providing an imagingfeature that allows the user to visualize the skin and sub-dermalregions of interest before treatment. In one embodiment, the systemallows the user to place a transducer module at optimal locations on theskin and provides feedback information to assure proper skin contact. Inone embodiment, the therapeutic system provides an ultrasonic transducermodule that directs acoustic waves to the treatment area. This acousticenergy heats tissue as a result of frictional losses during energyabsorption, producing a discrete zone of coagulation.

The present disclosure may be described herein in terms of variousfunctional components and processing steps. For simplicity, the nextpart of the present disclosure illustrates three methods and systems: amethod and system for performing a brow lift, a method and system forperforming a blepharoplasty, and a method and system for treatingcartilage; however, such methods and systems can be suitably appliedand/or for other tissue applications. Further, while specific hardwareand software components are mentioned and described throughout, othercomponents configured to perform the same function can also be utilized.

Method and System for Performing a Brow Lift

With reference to FIGS. 1-8 and according to one embodiment, a methodand system is provided for treating tissue along a patient's foreheadwith focused, unfocused or defocused energy to elevate the patient'seyebrows and reduce wrinkles to perform a brow lift. In an embodiment,the energy used is ultrasound energy. In other embodiments, the energyis laser energy or radio frequency energy. In certain embodiments, theenergy is ultrasound energy combined with other forms of energy such aslaser or radio frequency energy. The method will be referred to asmethod 10 throughout. In an embodiment, with particular reference toFIG. 3 , the treated tissue region 1 comprises subcutaneous tissue 2 andcan comprise muscle, tendon, ligament or cartilage tissue (MTLC), amongother types of tissue. It should be noted that references throughoutthis specification to tissue 1 include subcutaneous tissue 2 andreferences to subcutaneous tissue 2 include tissue 1.

Subcutaneous tissue 2 is wrinkle generating subcutaneous tissue locatedwithin a Region of Interest (ROI) 12, e.g., as illustrated in FIG. 2 ,which is on a patient's forehead or forehead region in an embodiment.ROI 12 may comprise an inner treatment region, a superficial region, asubcutaneous region of interest and/or any other region of interest inbetween an inner treatment region, a superficial region, and/or asubcutaneous region within a patient, and/or combinations thereof.

As depicted in the embodiment shown in FIG. 1 , method 10 broadlycomprises the following steps A-D. First, in step A, a system that emitsenergy such as ultrasound energy is provided. In one embodiment, thissystem is also configured to obtain images. At step B, energy is appliedto a region of interest which comprises the patient's forehead region.The energy is applied until a certain bio-effect is achieved at step C.Upon the completion of bio-effects at step C, a brow lift is completedat step D.

The bio-effects may produce a clinical outcome such as a brow lift whichcan comprise elevating the patient's eyebrows and reducing wrinkles onthe patient's brow or forehead region. The clinical outcome may be thesame as traditional invasive surgery techniques, and may comprise theremoval of wrinkles through a brow lift or replacement of BOTOX-typetreatment. The term “BOTOX-type treatment” is meant to include treatingthe muscles and other tissue 1 and subcutaneous tissue 2 within theforehead with muscle relaxant drugs. One drug is sold under thetrademark BOTOX®. and is produced by the Allergan Corporation of Irvine,Calif. Other drugs include the DYSPORT®. drug produced by Ipsen, Inc. ofMilford, Mass. or the VISTABEL®. drug also produced by the AllerganCorporation.

FIG. 2 depicts an embodiment where method 10 is used to perform a browlift by targeting wrinkle generating subcutaneous tissue 2. Wrinkles canbe partially or completely removed by applying ultrasound energy at ROI12 along the patient's forehead at levels causing the desiredbio-effects. As noted above, the bio-effects can comprise ablating,micro-ablating, coagulating, severing, partially incapacitating,shortening, removing, or otherwise manipulating tissue 1 or subcutaneoustissue 2 to achieve the desired effect. As part of removing thesubcutaneous tissue 2, method 10 can be used to ablate, micro-ablate, orcoagulate a specific tissue. Further, in one embodiment, muscle 3 (suchas the corrugator supercilii muscle) can be paralyzed and permanentlydisabled and method 10 can be utilized to replace toxic BOTOX®.injections either completely or reduce the amount of BOTOX-typeinjections.

When method 10 is used in this manner, certain subcutaneous tissues suchas muscles are incapacitated and paralyzed or rendered incapable ofmovement. In one embodiment, the muscles within ROI 12 may be eithercut, ablated, coagulated, or micro-ablated in a manner such that themuscles may be no longer able of movement and be permanently paralyzeddue to the bio-effects from the application of energy such as ultrasoundenergy. The paralysis of the muscles may reduce or eliminate wrinkles onthe tissue. Unlike traditional BOTOX-type injections, the paralysis maybe permanent and the wrinkles may not reappear after treatment.Therefore, repeated treatments as with BOTOX-type treatments are notnecessary. Method 10 may be used on any area of the body of a patient toreplace traditional BOTOX-type injections. Examples include the foreheador neck area, or around the eyes to remove wrinkles referred to as“crow's feet.”

With continued reference to FIG. 2 and in an embodiment, the use ofultrasound energy 21 may replace the need for any invasive surgery toperform a brow lift. In this embodiment, a transducer may be coupled to,or positioned near a brow 126 and ultrasound energy may be emitted andtargeted to specific depths within ROI 12, which may produce variousbio-effects. These bio-effects may have the same effect as traditionalinvasive techniques without traditional or endoscopic surgery. Forexample, instead of making an incision across brow 126 to cut aparticular muscle such as the corrugator supercilii muscle or SMAS, theultrasound energy can be applied at ROI 12 to cut and/or remove aportion of the corrugator supercilii muscle or permanently paralyze anddisable the corrugator supercilii muscle or SMAS 8 and achieve the sameresults as traditional invasive brow lifts.

Method 10 may be used to perform any type of brow lift. For example, anendobrow or open brow lift of just the brow 126 may be performed. Inthis procedure, ROI 12 may comprise the upper eyelids 128 and eyebrows130. Alternatively, the brow lift may limit the ROI 12 to just theforehead muscles 132. In yet another embodiment, method 10 may beutilized in a similar manner to replace traditional surgical techniquesto perform an entire face lift.

Turning now to the embodiment depicted in FIGS. 3-5 , energy such asultrasound energy 21 is delivered at specific depths below the skin of apatient to treat tissue 1 and subcutaneous tissue 2. Certainsubcutaneous tissues 2 which may be treated by method 10 may comprisemuscles 3, fascia 7, the Superficial Muscular Aponeurotic System(“SMAS”) 8, fat 9, as well as ligament and cartilage tissue.

The application of energy to ROI 12 may produce certain desiredbio-effects on tissue 1 and/or subcutaneous tissue 2 by affecting thesetissues that are responsible for wrinkles along brow 126. Thebio-effects may comprise, but are not limited to, ablating, coagulating,microablating, severing, partially incapacitating, rejuvenating,shortening, or removing tissue 1 and/or subcutaneous tissue 2 eitherinstantly or over longer time periods. Specific bio-effects may be usedto treat different subcutaneous tissues 2 to produce differenttreatments as described in greater detail below.

In an embodiment, with reference to FIGS. 3-5 , various differenttissues 1 or subcutaneous tissues 2 may be treated by method 10 toproduce different bio-effects. In order to treat a specific subcutaneoustissue 2 to achieve a desired bio-effect, ultrasound energy 21 may bedirected to a specific depth within ROI 12 to reach the targetedsubcutaneous tissue 2. For example, if it is desired to cut muscle 3such as the corrugator supercilii muscle (by applying ultrasound energy21 at ablative or coagulative levels), which is approximately 15 mmbelow the surface of the skin, ultrasound energy 21 may be provided atROI 12 at a level to reach 15 mm below the skin at an ablative orcoagulative level which may be capable of ablating or coagulating muscle3.

In an embodiment, the energy level for ablating tissue such as muscle 3is in the range of approximately 0.1 joules to 10 joules to create anablative lesion. Further, the amount of time energy such as ultrasoundenergy 21 is applied at these power levels to create a lesion varies inthe range from approximately 1 millisecond to several minutes. Thefrequency of the ultrasound energy is in the range between approximately2-12 MHz and more specifically in the range of approximately 3-7 MHz.Certain times are in the range of approximately 1 millisecond to 200milliseconds. In an embodiment where a legion is being cut into thecorrugator supercilii muscle, approximately 1.5 joules of power isapplied for about 40 milliseconds. Applying ultrasound energy 21 in thismanner can cause ablative lesions in the range of approximately 0.1cubic millimeters to about 1000 cubic millimeters. A smaller lesion canbe in the range of about 0.1 cubic millimeters to about 3 cubicmillimeters. Cutting the corrugator supercilii muscle in this manner mayparalyze and permanently disable the corrugator supercilii muscle.

An example of ablating muscle 3 is depicted in FIG. 5 which depicts aseries of lesions 27 cut into muscle 3. Besides ablating or coagulatingmuscle 3, other bio-effects may comprise incapacitating, partiallyincapacitating, severing, rejuvenating, removing, ablating,micro-ablating, coagulating, shortening, cutting, manipulating, orremoving tissue 1 either instantly or over time and/or other effects,and/or combinations thereof. In an embodiment, muscle 3 can comprise thefrontalis muscle, the corrugator supercilii muscle, the epicraniusmuscle, or the procerus muscle.

Different tissues 1 and subcutaneous tissues 2 within the ROI 12 mayhave different acoustic properties. For example, the corrugatorsupercilii muscle might have different acoustic properties than thefrontalis muscle or fat disposed along the brow. These differentacoustic properties affect the amount of energy applied to ROI 12 tocause certain bio-effects to the corrugator supercilii muscle than maybe required to achieve the same or similar bio-effects for the frontalismuscle. These acoustic properties may comprise the varied acoustic phasevelocity (speed of sound) and its potential anisotropy, varied massdensity, acoustic impedance, acoustic absorption and attenuation, targetsize and shape versus wavelength, and direction of incident energy,stiffness, and the reflectivity of tissue 1 and subcutaneous tissues 2,among many others. Depending on the acoustic properties of a particulartissue 1 or subcutaneous tissue 2 being treated, the application ofultrasound energy 21 at ROI 12 may be adjusted to best compliment theacoustic property of tissue 1 or subcutaneous tissue 2 being targeted.

Depending at least in part upon the desired bio-effect and thesubcutaneous tissue 2 being treated, method 10 may be used with anextracorporeal, non-invasive, partially invasive, or invasive procedure.Also, depending at least in part upon the specific bio-effect andsubcutaneous tissue 2 targeted, there may be temperature increaseswithin ROI 12 which may range from approximately 0-60° C. or heating,cavitation, steaming, and/or vibro-acoustic stimulation, and/orcombinations thereof.

Besides producing various bio-effects to tissue 1, method 10 and theassociated ultrasound system may also be used for imaging. The imagingmay be accomplished in combination with the treatments described herein,or it may be accomplished as a separate function to locate tissue 1 orsubcutaneous tissue 2 to be targeted. In an embodiment, the imaging ofROI 12 may be accomplished in real time as the treatment is beingadministered. This may assist visualization of certain movingsubcutaneous tissue 2 during treatment. In other embodiments, the usermay simply know where the specific subcutaneous tissue 2 is based onexperience and not require imaging.

Throughout this application, reference has been made to treating asingle layer of tissue 1 at any given time. It should be noted that twoor more layers of tissue (both the skin and subcutaneous tissue 2) maybe treated at the same time and fall within the scope of thisdisclosure. In this embodiment, the skin may be treated along withsubcutaneous tissues 2. In other embodiments where two or more layers oftissue are treated, muscle 3, ligaments 5, and SMAS 8 can be treatedsimultaneously.

In another embodiment, method 10 can be used to assist in delivery ofvarious fillers and other medicines to ROI 12. According to thisembodiment, ultrasound energy 21 assists in forcing the fillers andmedicants into tissue 1 and subcutaneous tissue 2 at ROI 12. Hyaluronicacid can be delivered to ROI 12 in this manner. The application ofultrasound energy 21 to ROI 12 causes surrounding tissues to absorb thefillers such as hyaluronic acid by increasing the temperature at ROI 12and through the mechanical effects of ultrasound such as cavitation andstreaming. Utilizing ultrasound energy 21 to effectuate the delivery ofmedicants and fillers is described in U.S. patent application Ser. No.11/163,177 entitled “Method and System for Treating Acne and SebaceousGlands” which is been incorporated by reference in its entirety, herein.

Turning now to the embodiment depicted in FIGS. 6-8 , an system 14 foremitting energy to effectuate a brow lift is an ultrasound system 16that may be capable of emitting ultrasound energy 21 that is focused,unfocused or defocused to treat tissue 1 and subcutaneous tissue 2 atROI 12. System 14 may comprise a probe 18, a control system 20, and adisplay 22. System 14 may be used to delivery energy to, and monitor,ROI 12. Certain embodiments of systems may be disclosed in U.S. patentapplication Ser. No. 11/163,177 entitled “Method and System for TreatingAcne and Sebaceous Glands,” U.S. patent application Ser. No. 10/950,112entitled “Method and System for Combined Ultrasound Treatment”, and U.S.Patent Application No. 60/826,039 entitled “Method and System forNon-Ablative Acne Treatment”, each of which are hereby incorporated byreference in their entirety.

With reference to FIG. 7 , an embodiment of a probe 18 may be atransducer 19 capable of emitting ultrasound energy 21 into ROI 12. Thismay heat ROI 12 at a specific depth to target a specific tissue 1 orsubcutaneous tissue 2 causing that tissue to be ablated, micro-ablated,coagulated, incapacitated, partially incapacitated, rejuvenated,shortened, paralyzed, or removed. Certain tissues that are targetedcomprise the corrugator supercilii muscle, the frontalis muscle, theprocerus muscle, and/or the epicranius muscle or other muscle disposedalong the patient's forehead.

A coupling gel may be used to couple probe 18 to ROI 12 at the patient'sforehead. Ultrasound energy 21 may be emitted in various energy fieldsin this embodiment. With additional reference to FIG. 7A and FIG. 7B andin this embodiment, the energy fields may be focused, defocused, and/ormade substantially planar by transducer 19, to provide many differenteffects. Energy may be applied in a C-plane or C-scan. For example, inone embodiment, a generally substantially planar energy field mayprovide a heating and/or pretreatment effect, a focused energy field mayprovide a more concentrated source of heat or hypothermal effect, and anon-focused energy field may provide diffused heating effects. It shouldbe noted that the term “non-focused” as used throughout encompassesenergy that is unfocused or defocused.

In another embodiment, a transducer 19 may be capable of emittingultrasound energy 21 for imaging or treatment or combinations thereof.In an embodiment, transducer 19 may be configured to emit ultrasoundenergy 21 at specific depths in ROI 12 to target a specific tissue suchas a corrugator supercilii muscle as described below. In this embodimentof FIG. 7 , transducer 19 may be capable of emitting unfocused ordefocused ultrasound energy 21 over a wide area in ROI 12 for treatmentpurposes.

Transducer 19 may comprise one or more transducers for facilitatingtreatment. Transducer 19 may further comprise one or more transductionelements 26, e.g., elements 26A or 26B (see FIGS. 7A and 7B). Thetransduction elements 26 may comprise piezoelectrically active material,such as lead zirconante titanate (PZT), or other piezoelectricallyactive material such as, but not limited to, a piezoelectric ceramic,crystal, plastic, and/or composite materials, as well as lithiumniobate, lead titanate, barium titanate, and/or lead metaniobate. Inaddition to, or instead of, a piezoelectrically active material,transducer 19 may comprise any other materials configured for generatingradiation and/or acoustical energy. Transducer 19 may also comprise oneor more matching and/or backing layers configured along with thetransduction element 26, such as being coupled to the piezoelectricallyactive material. Transducer 19 may also be configured with single ormultiple damping elements along the transduction element 26.

In an embodiment, the thickness of the transduction element 26 oftransducer 19 may be configured to be uniform. That is, the transductionelement 26 may be configured to have a thickness that is generallysubstantially the same throughout.

In another embodiment, the transduction element 26 may also beconfigured with a variable thickness, and/or as a multiple dampeddevice. For example, the transduction element 26 of transducer 19 may beconfigured to have a first thickness selected to provide a centeroperating frequency of a lower range, for example from approximately 1kHz to 3 MHz. The transduction element 26 may also be configured with asecond thickness selected to provide a center operating frequency of ahigher range, for example from approximately 3 to 100 MHz or more.

In yet another embodiment, transducer 19 may be configured as a singlebroadband transducer excited with two or more frequencies to provide anadequate output for raising the temperature within ROI 12 to the desiredlevel. Transducer 19 may also be configured as two or more individualtransducers, wherein each transducer 19 may comprise a transductionelement 26. The thickness of the transduction elements 26 may beconfigured to provide center-operating frequencies in a desiredtreatment range. For example, in an embodiment, transducer 19 maycomprise a first transducer 19 configured with a first transductionelement 26A having a thickness corresponding to a center frequency rangeof approximately 1 MHz to 3 MHz, and a second transducer 19 configuredwith a second transduction element 26B having a thickness correspondingto a center frequency of approximately 3 MHz to 100 MHz or more. Variousother ranges of thickness for a first and/or second transduction element26 can also be realized.

Moreover, in an embodiment, any variety of mechanical lenses or variablefocus lenses, e.g. liquid-filled lenses, may also be used to focus andor defocus the energy field. For example, with reference to theembodiments depicted in FIGS. 7A and 7B, transducer 19 may also beconfigured with an electronic focusing array 24 in combination with oneor more transduction elements 26 to facilitate increased flexibility intreating ROI 12. Array 24 may be configured in a manner similar totransducer 19. That is, array 24 may be configured as an array ofelectronic apertures that may be operated by a variety of phases viavariable electronic time delays, for example, T1, T2, T3 . . . Tj. Bythe term “operated,” the electronic apertures of array 24 may bemanipulated, driven, used, and/or configured to produce and/or deliverenergy in a manner corresponding to the phase variation caused by theelectronic time delay. For example, these phase variations may be usedto deliver defocused beams, planar beams, and/or focused beams, each ofwhich may be used in combination to achieve different physiologicaleffects in ROI 12.

Transduction elements 26 may be configured to be concave, convex, and/orplanar. For example, in the embodiment depicted in FIG. 7A, transductionelements 26A and 26B are configured to be concave in order to providefocused energy for treatment of ROI 12. Additional embodiments aredisclosed in U.S. patent application Ser. No. 10/944,500, entitled“System and Method for Variable Depth Ultrasound Treatment,”incorporated herein by reference in its entirety.

In another embodiment, depicted in FIG. 7B, transduction elements 26Aand 26B may be configured to be substantially flat in order to providesubstantially uniform energy to ROI 12. While FIGS. 7A and 7B depictembodiments with transduction elements 26 configured as concave andsubstantially flat, respectively, transduction elements 26 may beconfigured to be concave, convex, and/or substantially flat. Inaddition, transduction elements 26 may be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element 26 may be configured to beconcave, while a second transduction element 26 may be configured to besubstantially flat.

Moreover, transduction element 26 can be any distance from the patient'sskin. In that regard, it can be far away from the skin disposed within along transducer or it can be just a few millimeters from the surface ofthe patient's skin. In certain embodiments, positioning the transductionelement 26 closer to the patient's skin is better for emittingultrasound at high frequencies. Moreover, both three and two dimensionalarrays of elements can be used in the present invention.

With reference to FIGS. 7C and 7D, transducer 19 may also be configuredas an annular array to provide planar, focused and/or defocusedacoustical energy. For example, in an embodiment, an annular array 28may comprise a plurality of rings 30, 32, 34 to N. Rings 30, 32, 34 to Nmay be mechanically and electrically isolated into a set of individualelements, and may create planar, focused, or defocused waves. Forexample, such waves can be centered on-axis, such as by methods ofadjusting corresponding transmit and/or receive delays, T1, T2, T3 . . .TN. An electronic focus may be suitably moved along various depthpositions, and may enable variable strength or beam tightness, while anelectronic defocus may have varying amounts of defocusing. In anembodiment, a lens and/or convex or concave shaped annular array 28 mayalso be provided to aid focusing or defocusing such that any timedifferential delays can be reduced. Movement of annular array 28 in one,two or three-dimensions, or along any path, such as through use ofprobes and/or any conventional robotic arm mechanisms, may beimplemented to scan and/or treat a volume or any corresponding spacewithin ROI 12.

With reference to FIG. 7E, another transducer 19 can be configured tocomprise a spherically focused single element 36, annular/multi-element38, annular with imaging region(s) 40, line-focused single element 42,1-D linear array 44, 1-D curved (convex/concave) linear array 46, and/or2-D array 48, with mechanical focus 50, convex lens focus 52, concavelens focus 54, compound/multiple lens focused 56, and/or planar arrayform 58 to achieve focused, unfocused, or defocused sound fields forboth imaging and/or therapy.

Transducer 19 may further comprise a reflective surface, tip, or area atthe end of the transducer 19 that emits ultrasound energy 21. Thisreflective surface may enhance, magnify, or otherwise change ultrasoundenergy 21 emitted from system 14.

In an embodiment, suction is used to attach probe 18 to the patient'sbody. In this embodiment, a negative pressure differential is createdand probe 18 attaches to the patient's skin by suction. A vacuum-typedevice is used to create the suction and the vacuum device can beintegral with, detachable, or completely separate from probe 18. Thesuction attachment of probe 18 to the skin and associated negativepressure differential ensures that probe 18 is properly coupled to thepatient's skin. Further, the suction-attachment also reduces thethickness of the tissue to make it easier to reach the targeted tissue.In other embodiments, a coupling gel is used to couple probe 18 to thepatient's skin. The coupling gel can include medicines and other drugsand the application of ultrasound energy 21 can facilitate transdermaldrug delivery.

An probe 18 may be suitably controlled and operated in various mannersby control system 20 as depicted in FIGS. 8A-8C which also relays andprocesses images obtained by transducer 19 to display 22. In theembodiment depicted in FIGS. 8A-8C, control system 20 may be capable ofcoordination and control of the entire treatment process to achieve thedesired therapeutic effect on tissue 1 and subcutaneous tissue 2 withinROI 12. For example, in an embodiment, control system 20 may comprisepower source components 60, sensing and monitoring components 62,cooling and coupling controls 64, and/or processing and control logiccomponents 66. Control system 20 may be configured and optimized in avariety of ways with more or less subsystems and components to implementthe therapeutic system for controlled targeting of the desired tissue 1or subcutaneous tissue 2, and the embodiments in FIGS. 8A-8C are merelyfor illustration purposes.

For example, for power sourcing components 60, control system 20 maycomprise one or more direct current (DC) power supplies 68 capable ofproviding electrical energy for the entire control system 20, includingpower required by a transducer electronic amplifier/driver 70. A DCcurrent sense device 72 may also be provided to confirm the level ofpower entering amplifiers/drivers 70 for safety and monitoring purposes,among others.

In an embodiment, amplifiers/drivers 70 may comprise multi-channel orsingle channel power amplifiers and/or drivers. In an embodiment fortransducer array configurations, amplifiers/drivers 70 may also beconfigured with a beamformer to facilitate array focusing. An beamformermay be electrically excited by an oscillator/digitally controlledwaveform synthesizer 74 with related switching logic.

Power sourcing components 60 may also comprise various filteringconfigurations 76. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 70 to increasethe drive efficiency and effectiveness. Power detection components 78may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 78 maybe used to monitor the amount of power entering probe 18.

Various sensing and monitoring components 62 may also be suitablyimplemented within control system 20. For example, in an embodiment,monitoring, sensing, and interface control components 80 may be capableof operating with various motion detection systems implemented withinprobe 18, to receive and process information such as acoustic or otherspatial and temporal information from ROI 12. Sensing and monitoringcomponents 62 may also comprise various controls, interfacing, andswitches 82 and/or power detectors 78. Such sensing and monitoringcomponents 62 may facilitate open-loop and/or closed-loop feedbacksystems within treatment system 14.

In an embodiment, sensing and monitoring components 62 may furthercomprise a sensor that may be connected to an audio or visual alarmsystem to prevent overuse of system 14. In this embodiment, the sensormay be capable of sensing the amount of energy transferred to the skin,and/or the time that system 14 has been actively emitting energy. When acertain time or temperature threshold has been reached, the alarm maysound an audible alarm, or cause a visual indicator to activate to alertthe user that a threshold has been reached. This may prevent overuse ofthe system 14. In an embodiment, the sensor may be operatively connectedto control system 20 and force control system 20, to stop emittingultrasound energy 21 from transducer 19.

In an embodiment, a cooling/coupling control system 84 may be provided,and may be capable of removing waste heat from probe 18. Furthermore thecooling/coupling control system 84 may be capable of providing acontrolled temperature at the superficial tissue interface and deeperinto tissue, and/or provide acoustic coupling from probe 18 to ROI 12.Such cooling/coupling control systems 84 can also be capable ofoperating in both open-loop and/or closed-loop feedback arrangementswith various coupling and feedback components.

Additionally, an control system 20 may further comprise a systemprocessor and various digital control logic 86, such as one or more ofmicrocontrollers, microprocessors, field-programmable gate arrays,computer boards, and associated components, including firmware andcontrol software 88, which may be capable of interfacing with usercontrols and interfacing circuits as well as input/output circuits andsystems for communications, displays, interfacing, storage,documentation, and other useful functions. System software 88 may becapable of controlling all initialization, timing, level setting,monitoring, safety monitoring, and all other system functions requiredto accomplish user-defined treatment objectives. Further, variouscontrol switches 90 may also be suitably configured to controloperation.

With reference to FIG. 8C, an transducer 19 may be controlled andoperated in various manners by a hand-held format control system 92. Anexternal battery charger 94 can be used with rechargeable-type batteries96 or the batteries can be single-use disposable types, such as M-sizedcells. Power converters 98 produce voltages suitable for powering adriver/feedback circuit 100 with tuning network 102 driving transducer19 which is coupled to the patient via one or more acoustic couplingcaps 104. Cap 104 can be composed of at least one of a solid media,semi-solid e.g. gelatinous media, and/or liquid media equivalent to anacoustic coupling agent (contained within a housing). Cap 104 is coupledto the patient with an acoustic coupling agent 106. In addition, amicrocontroller and timing circuits 108 with associated software andalgorithms provide control and user interfacing via a display 110,oscillator 112, and other input/output controls 114 such as switches andaudio devices. A storage element 116, such as an Electrically ErasableProgrammable Read-Only Memory (“EEPROM”), secure EEPROM, tamper-proofEEPROM, or similar device holds calibration and usage data. A motionmechanism with feedback 118 can be suitably controlled to scan thetransducer 19, if desirable, in a line or two-dimensional pattern and/orwith variable depth. Other feedback controls comprise a capacitive,acoustic, or other coupling detection means and/or limiting controls 120and thermal sensor 122. A combination of the secure EEPROM with at leastone of coupling caps 104, transducer 19, thermal sensor 122, couplingdetectors, or tuning network. Finally, an transducer can furthercomprise a disposable tip 124 that can be disposed of after contacting apatient and replaced for sanitary reasons.

With reference again to FIG. 3 , an system 14 also may comprise display22 capable of providing images of ROI 12 in certain embodiments whereultrasound energy 21 may be emitted from transducer 19 in a mannersuitable for imaging. In an embodiment, display 22 is a computermonitor. Display 22 may be capable of enabling the user to facilitatelocalization of the treatment area and surrounding structures, e.g.,identification of subcutaneous tissue 2. In an alternative embodiment,the user may know the location of the specific subcutaneous tissue 2 tobe treated based at least in part upon prior experience or education.

After localization, ultrasound energy 21 is delivered at a depth,distribution, timing, and energy level to achieve the desiredtherapeutic effect at ROI 12 to treat tissue 1. Before, during and/orafter delivery of ultrasound energy 21, monitoring of the treatment areaand surrounding structures may be conducted to further plan and assessthe results and/or provide feedback to control system 20, and to asystem operator via display 22. In an embodiment, localization may befacilitated through ultrasound imaging that may be used to define theposition of a desired tissue 1 or subcutaneous tissue 2 in ROI 12.

For ultrasound energy 21 delivery, transducer 19 may be mechanicallyand/or electronically scanned to place treatment zones over an extendedarea in ROI 12. A treatment depth may be adjusted between a range ofapproximately 1 to 30 millimeters, and/or the greatest depth of tissue 1or subcutaneous tissue 2. Such delivery of energy may occur throughimaging of the targeted tissue 1, and then applying ultrasound energy 21at known depths over an extended area without initial or ongoingimaging.

The ultrasound beam from transducer 19 may be spatially and/ortemporally controlled at least in part by changing the spatialparameters of transducer 19, such as the placement, distance, treatmentdepth and transducer 19 structure, as well as by changing the temporalparameters of transducer 19, such as the frequency, drive amplitude, andtiming, with such control handled via control system 20. Such spatialand temporal parameters may also be suitably monitored and/or utilizedin open-loop and/or closed-loop feedback systems within ultrasoundsystem 16.

Finally, it should be noted that while this disclosure is directedprimarily to using ultrasound energy 21 to conduct proceduresnon-invasively, that the method and system for performing a brow liftdescribed above can also utilize energy such as ultrasound energy 21 toassist in invasive procedures. For example, ultrasound energy 21 can beused to ablate subcutaneous tissues 2 and tissues 1 during an invasiveprocedure. In this regard, ultrasound energy 21 can be used for invasiveand minimally invasive procedures.

Method and System for Performing a Blepharoplasty

With reference to FIGS. 9-16 and in accordance with an embodiment, amethod and system are provided for treating tissue around the eyes withfocused, unfocused or defocused energy to perform a non-invasiveblepharoplasty. In an embodiment, the energy used is ultrasound energy.In other embodiments, the energy is laser energy or radio frequencyenergy. In certain embodiments, the energy is ultrasound energy combinedwith other forms of energy such as laser or radio frequency energy. Themethod will be referred to as method 110 throughout. In an embodiment,the treated tissue region comprises skin and subcutaneous tissue 12comprising muscle, tendon, ligament or cartilage tissue (“MTLC”), otherfibrous tissue, fascial tissue, and/or connective tissue and any othertypes of tissue. It should be noted that references throughout thisspecification to tissue 11 include subcutaneous tissue 12.

As depicted in the embodiment shown in FIG. 9 , method 110 broadlycomprises the following steps 1A-1D. First, in step 1A, a system thatemits energy such as ultrasound energy is provided. In one embodimentwith reference to FIG. 12 , this system is also configured to obtainimages. At step 1B, energy is applied to a Region of Interest (“ROI”)which is part of or near the patient's eyes, or eye region whichincludes the eye sockets, eyelids, cheeks, the area below the eyes, andthe area around the side of the patient's face adjacent to the eyes. Theenergy is applied until a certain bio-effect is achieved at step 1C. Thebio-effects at step 1C reduce the laxity of the tissue around the eyesand thus, reduce wrinkles. Upon the completion of bio-effects at step1C, a blepharoplasty is achieved at step 1D.

Turning now to FIGS. 10A and 10B, method 110 is used to perform anon-invasive blepharoplasty by ablating portions of fat, muscle, andother subcutaneous and/or connective tissues at the ROI located around apatient's eyes. As part of ablating portions of subcutaneous tissues,method 110 ablates or micro-ablates tissue and subcutaneous tissuescomprising, but not limited to, fat and muscle. By ablating and treatingthese subcutaneous tissues, wrinkles on the skin and sagging skin areremoved because the subcutaneous foundation for the skin is treated.Further, in one embodiment, the muscle can be paralyzed and method 110can be utilized to replace toxic BOTOX®. injections to remove any crow'sfeet 1129 located adjacent to the patient's eyes. Method 110 can be usedto supplement or replace BOTOX-type treatments in this manner. The term“BOTOX-type treatment” or “BOTOX-type injections” are meant to includetreating the muscles and other tissue 1 and subcutaneous tissue 2 withinthe forehead with muscle relaxant drugs. One drug is sold under thetrademark BOTOX®. and is produced by the Allergan Corporation of Irvine,Calif. Other drugs include the DYSPORT®. drug produced by Ipsen, Inc. ofMilford, Mass. or the VISTABEL®. drug also produced by the AllerganCorporation.

FIG. 10A shows one embodiment where method 110 is used to perform anon-invasive upper lid blepharoplasty and to remove crow's feet 1129around a patient's eye region 1132. As used throughout, eye region 1132is meant to encompass the area around the eyes including the eyesockets, the orbital septum, lower and upper eyelids, eyebrows, and thearea directly adjacent to the corners of the eye where crow's feet 1129form. In this embodiment, pockets of fat 1126 around the upper eyelid1128 can be removed or otherwise ablated, coagulated, or treated asnoted herein. Further, muscle can also be caused to be reabsorbed intothe body (thus removed) as can other tissue or subcutaneous tissue.

Tissue such as fat pockets 1126 is caused to be reabsorbed into the bodyby applying energy such as ultrasound energy at specific depths belowthe surface of the skin at levels where the targeted tissue is ablated,micro-ablated, or coagulated. For example, if fat pockets 1126 arelocated fifteen millimeters from the surface of the skin, ultrasoundenergy 121 is applied at a depth of fifteen millimeters at ablativelevels to destroy and cause fat pockets 1126 to be reabsorbed into thebody. Portions of muscle can also be ablated and subsequently reabsorbedinto the ROI 112 as well (effectively removing the reabsorbed tissuefrom the ROI).

Ultrasound energy 121 can be applied at various frequencies, powerlevels, and times to target and effect subcutaneous tissue 112. Certainfrequencies include anywhere in the range of approximately 2-12 MHz andmore specifically in the range of approximately 3-7 MHz. Certain timeframes to create ablative lesions within subcutaneous tissue 21 are inthe range of approximately a few milliseconds to several minutes.Further, certain power ranges to create ablative lesions in subcutaneoustissue 12 are in the range of approximately 0.1 joules to 10 joules.Applying ultrasound energy 121 in this manner produces ablative lesionsin subcutaneous tissue in the range of approximately 0.1 cubicmillimeters to a 1000 cubic millimeters. Certain smaller lesions are inthe range of approximately 0.1 cubic millimeters to 3 cubic millimeters.

In an embodiment, the application of ultrasound energy 121 to ROI 112also causes the regeneration, remodeling, and shrinkage of tissue 12.With respect to regeneration and remodeling, the application ofultrasound energy 121 to ROI 112 causes thermal and mechanical affectswhich cause injury to subcutaneous tissues 12 and tissues 11. Theseinjuries to tissues 11 and subcutaneous tissues 12 cause variouschemical processes that lead to certain protein's repair andregeneration. Certain proteins comprise, but are not necessary limitedto, collagen, myosin, elastin, and actin. In addition to proteins, fatcalls are affected. As these proteins and fat are being repaired andregenerated, the amount of tissue 11 and subcutaneous tissues 12 areincreased. This overall increase in tissue mass can cause voids orpockets in tissue 12 to be filled with the excess subcutaneous tissue 12which also reduces wrinkles at ROI 12.

FIG. 10B shows one embodiment for a lower lid blepharoplasty wherepockets of fat 1126 around a lower eyelid 1131 are ablated,micro-ablated, or coagulated and caused to be reabsorbed into the bodyby the application of ultrasound energy as described above. Further,portions of muscle can also be caused to be reabsorbed into the body ascan other subcutaneous tissue by similar methods. When fat and othersubcutaneous tissue is reabsorbed into the body, puffiness around theeyes is reduced as on of the bio-effects achieved by the application ofultrasound energy.

With continued reference to FIGS. 10A-10B, in an embodiment, transducer119 may be coupled to or positioned near the eye region 1132 andultrasound energy 121 may be emitted from probe 118 at specific depthswithin ROI 112 which may produce various bio-effects. These bio-effectsmay have the same effect as traditional invasive techniques and cancomprise ablating, micro-ablating, coagulating, severing, or cutting,partially incapacitating, shortening or removing tissue 11 from ROI 112.These bio-effects have the same effects as a traditional blepharoplastyprocedure but accomplish a blepharoplasty in a non-invasive manner.

For example, instead of making an incision across the eyelids 1130 and1131 to remove fat pockets 1126, ultrasound energy 121 can be applied atROI 12 to ablate, coagulate, and/or cause fat to be reabsorbed into thebody such as fat pockets 1126 or muscle and achieve the same results astraditional invasive blepharoplasty procedures or a traditionaltransconjunctival blepharoplasty. Method 110 may be used to perform anytype of blepharoplasty including an upper lid blepharoplasty, a lowerlid blepharoplasty, or a transconjunctival blepharoplasty.

In one embodiment, method 110 can be used to replace traditionalBOTOX-type treatments and other medicants or fillers as described below.In other embodiments, method 10 can be use to assist in transdermal drugdelivery of BOTOX-type drugs and other medicines, medicants and fillers.In these embodiments, the application of ultrasound energy 121 to theROI increases the temperature at ROI 112. This increased temperatureassists in the transdermal delivery of BOTOX-type drugs. In otherembodiments, the application of ultrasound energy to the ROI causesmechanical effects such as cavitation and streaming which essentiallyhelps “push” the medicines into the patient's tissue.

In one embodiment, method 110 can also be effectively used to removecrow's feet 1129. Crow's feet 1129 can be removed by paralyzing theorbicularis oculi muscle which is typically accomplished with BOTOX-typeinjections. Applying ultrasound energy 121 at specific depths to contactthe orbicularis oculi muscle can incapacitate or otherwise paralyze theorbicularis oculi muscle. The orbicularis oculi muscle including theorbital part, the palpebral part, and the orbicularis oculi muscle canbe treated in accordance with the present invention. For example, in oneembodiment, ultrasound energy can be applied at the ROI to make severallesions in the orbicularis oculi muscle which incapacitates andparalyzes the muscle. With the orbicularis oculi muscle paralyzed,crow's feet 1129 disappear just as they would with traditionalBOTOX-type injections that paralyze the orbicularis oculi muscle.

When method 110 is utilized to replace traditional BOTOX-typeinjections, the muscles are incapacitated to a point where they areparalyzed or rendered incapable of movement. In one embodiment, themuscles within the ROI may be either ablated, micro-ablated, orcoagulated in a manner such that the muscles may be no longer be capableof movement, and be permanently paralyzed due to the bio-effects fromthe application of energy such as ultrasound energy 121. The paralysisof the muscles may reduce or eliminate wrinkles on the tissue such ascrow's feet 1129. Unlike traditional BOTOX-type injections, theparalysis may be permanent and the wrinkles may not reappear aftertreatment. Therefore, repeated treatments as with BOTOX-type treatmentsare not necessary. Method 110 may be used on any area of the patient'sbody to replace traditional BOTOX-type injections.

In another embodiment, method 110 can be used to perform a combinationblepharoplasty and midcheek lift. The ability to utilize energy such asultrasound energy to perform face lifts such as a midcheek lift isdescribed in patent application Ser. No. 11/163,151 entitled “Method andSystem For Noninvasive Face Lifts and Deep Tissue Tightening” which isherein incorporated in its entirety by reference. In this procedure,ultrasound energy is applied below the eyes to ablate or coagulatesubcutaneous tissue and move tissue and subcutaneous tissue upwards toperform a midcheek lift. In this embodiment, both this procedure and ablepharoplasty can be completed utilizing ultrasound energy to targetand ablate or coagulate subcutaneous tissue such as fibro-musculartissue.

In an embodiment where a midcheek lift is being performed in conjunctionwith a blepharoplasty, imaging can take place as discussed above tomonitor the effects on the tissue. Therefore, the operator of the systemcan vary the amount of ultrasound energy being emitted from the systemif necessary.

In another embodiment, method 110 can be used to assist in delivery ofvarious fillers and other medicines to ROI 112. According to thisembodiment, ultrasound energy 121 assists in forcing the fillers andmedicants into tissue 11 and subcutaneous tissue 12 at ROI 112.Hyaluronic acid can be delivered to ROI 112 in this manner. Theapplication of ultrasound energy 121 to ROI 112 causes surroundingtissues to absorb the fillers such as hyaluronic acid by increasing thetemperature at ROI 112 thereby increasing absorption and through themechanical effects of ultrasound such as cavitation and streaming.Utilizing ultrasound energy 21 to effectuate the delivery of medicantsand fillers is described in U.S. patent application Ser. No. 11/163,177entitled “Method and System for Treating Acne and Sebaceous Glands”which has been incorporated by reference in its entirety.

In an embodiment depicted in FIGS. 11-12 , a system is an ultrasoundsystem 116 that may be capable of emitting ultrasound energy 121 that isfocused, unfocused or defocused to treat tissue 11 at ROI 112. System114 may comprise a probe 118, a control system 120, and a display 122.System 114 may be used to deliver energy to, and monitor, ROI 112.Certain embodiments of systems may be disclosed in U.S. patentapplication Ser. No. 11/163,177 entitled “Method and System for TreatingAcne and Sebaceous Glands,” U.S. patent application Ser. No. 10/950,112entitled “Method and System for Combined Ultrasound Treatment”, and U.S.Patent Application No. 60/826,039 entitled “Method and System forNon-Ablative Acne Treatment”, all of which are hereby incorporated byreference in their entirety.

Moreover, with reference to FIGS. 12-14 , various different tissues 11or subcutaneous tissues 12 may be treated by method 110 to producedifferent bio-effects in an embodiment of the present invention. Inorder to treat a specific subcutaneous tissue 12 to achieve a desiredbio-effect, ultrasound energy 121 from system 114 may be directed to aspecific depth within ROI 112 to reach the targeted subcutaneous tissue12. For example, if it is desired to cut muscle 13 (by applyingultrasound energy 121 at ablative levels), which is approximately 15 mmbelow the surface of the skin, ultrasound energy 121 from ultrasoundsystem 116 may be provided at ROI 112 at a level to reach 15 mm belowthe skin at an ablative level which may be capable of ablating muscle13. An example of ablating muscle 13 is depicted in FIG. 14 whichdepicts a series of lesions 127 ablated into muscle 13. Besides ablatingmuscle 13, other bio-effects may comprise incapacitating, partiallyincapacitating, severing, rejuvenating, removing, ablating,micro-ablating, shortening, manipulating, or removing tissue 11 eitherinstantly or over time, and/or other effects, and/or combinationsthereof.

Depending at least in part upon the desired bio-effect and thesubcutaneous tissue 12 being treated, method 110 may be used with anextracorporeal, non-invasive, partially invasive, or invasive procedure.Also, depending at least in part upon the specific bio-effect and tissue11 targeted, there may be temperature increases within ROI 112 which mayrange from approximately 0-60° C. or heating, cavitation, steaming,and/or vibro-accoustic stimulation, and/or combinations thereof.

Besides producing various bio-effects to tissue 11, method 110 andultrasound system 116 may also be used for imaging. The imaging may beaccomplished in combination with the treatments described herein, or itmay be accomplished as a separate function to locate tissue 11 orsubcutaneous tissue 12 to be targeted. In an embodiment, the imaging ofROI 112 may be accomplished in real time as the treatment is beingadministered. This may assist visualization of certain movingsubcutaneous tissue 12 during treatment. In other embodiments, the usermay simply know where the specific subcutaneous tissue 12 is based onexperience and not require imaging.

In an embodiment depicted in FIGS. 12-14 , ultrasound energy 121 isdelivered at specific depths at and below the skin of a patient to treatsubcutaneous tissue 12. Subcutaneous tissue 12 which may also be treatedby method 110 may comprise muscles 13, fat 15, and various connectivetissue. Other subcutaneous tissues 12 which may be treated may comprisemuscle fascia, ligament, dermis 17, and various other tissues, such asthe Superficial Muscular Aponeurotic System (“SMAS”), and otherfibro-muscular tissues. Subcutaneous tissue 12 may be located within ROI112 on a patient's body that may be desired to be treated such as thepatient's eye region. In one embodiment, the area around the orbitalseptum is treated. ROI 112 may comprise an inner treatment region, asuperficial region, a subcutaneous region of interest and/or any otherregion of interest in between an inner treatment region, a superficialregion, and/or a subcutaneous region within a patient, and/orcombinations thereof.

The application of energy to ROI 112 may produce certain desiredbio-effects on tissue 11 and/or subcutaneous tissue 12. The bio-effectsmay comprise, but are not limited to, ablating, micro-ablating,coagulating, severing or cutting, partially incapacitating,rejuvenating, shortening, or removing tissue 12 either instantly or overlonger time periods by causing the tissue to be reabsorbed into thebody. Specific bio-effects may be used to treat different tissues 11 toproduce different treatments as described in greater detail below. Theseeffects on subcutaneous tissue 12 also enable the skin to be tighter andnot sag as its support layer of subcutaneous tissue 12 has been treatedby method 110.

Different tissues 11 and subcutaneous tissues 12 within ROI 112 may havedifferent acoustic properties. For example, muscle 13 might havedifferent acoustic properties than fascia or dermis 17. These differentacoustic properties affect the amount of energy applied to ROI 112 tocause certain bio-effects to muscle 13 than may be required to achievethe same or similar bio-effects for fascia. These acoustic propertiesmay comprise the varied acoustic phase velocity (speed of sound) and itspotential anisotropy, varied mass density, acoustic impedance, acousticabsorption and attenuation, target size and shape versus wavelength, anddirection of incident energy, stiffness, and the reflectivity ofsubcutaneous tissues 12, among many others. Depending on the acousticproperties of a particular tissue 11 or subcutaneous tissue 12 beingtreated, the application of ultrasound energy 121 at ROI 112 may beadjusted to best compliment the acoustic property of tissue 11 orsubcutaneous tissue 12 being targeted and treated.

In an embodiment, suction is used to attach probe 118 to the patient'sbody. In this embodiment, a negative pressure differential is createdand probe 118 attaches to the patient's skin by suction. A vacuum-typedevice is used to create the suction and the vacuum device can beintegral with, detachable, or completely separate from probe 118. Thesuction attachment of probe 118 to the skin and associated negativepressure differential ensures that probe 118 is properly coupled to skin185. Further, the suction-attachment also reduces the thickness of thetissue to make it easier to reach the targeted tissue. In otherembodiments, a coupling gel is used to couple probe 118 to the patient'sskin 185. The coupling gel can include medicines and other drugs and theapplication of ultrasound energy 121 can facilitate transdermal drugdelivery.

With additional reference to FIG. 15 , an embodiment of a probe 118 maybe a transducer 119 capable of emitting ultrasound energy 121 into ROI112. This may heat ROI 112 at a specific depth to target a specifictissue 11 or subcutaneous tissue 12 and causing that tissue to beablated, micro-ablated, incapacitated, coagulated, partiallyincapacitated, rejuvenated, shortened, paralyzed, or caused to bereabsorbed into the body. A coupling gel may be used to couple probe 118to ROI 112. Ultrasound energy 121 may be emitted in various energyfields in this embodiment. With additional reference to FIG. 15A andFIG. 15B, the energy fields may be focused, defocused, and/or madesubstantially planar by transducer 119 to provide many differenteffects. For example, energy may be applied in a C-plane or C-scan. Inone embodiment, a generally substantially planar energy field mayprovide a heating and/or pretreatment effect, a focused energy field mayprovide a more concentrated source of heat or hyperthermal effect, and anon-focused energy field may provide diffused heating effects. It shouldbe noted that the term “non-focused” as used throughout encompassesenergy that is unfocused or defocused.

Moreover, transduction element 126 can be any distance from thepatient's skin. In that regard, it can be far away from the skindisposed within a long transducer or it can be just a few millimetersfrom the surface of the patient's skin. In certain embodiments,positioning the transduction element 126 closer to the patient's skin isbetter for emitting ultrasound at high frequencies. Moreover, both threeand two dimensional arrays of elements can be used in the presentinvention.

In another embodiment, a transducer 119 may be capable of emittingultrasound energy 121 for imaging or treatment or combinations thereof.In an embodiment, transducer 119 may be configured to emit ultrasoundenergy 121 at specific depths in ROI 112 as described below. In thisembodiment of FIG. 112 , transducer 119 may be capable of emittingunfocused or defocused ultrasound energy 121 over a wide area in ROI 112for treatment purposes.

With continued reference to FIGS. 15A and 15B, transducer 119 maycomprise one or more transducers for facilitating treatment. Transducer119 may further comprise one or more transduction elements 126, e.g.,elements 126A or 126B. The transduction elements 126 may comprisepiezoelectrically active material, such as lead zirconante titanate(PZT), or other piezoelectrically active material such as, but notlimited to, a piezoelectric ceramic, crystal, plastic, and/or compositematerials, as well as lithium niobate, lead titanate, barium titanate,and/or lead metaniobate. In addition to, or instead of, apiezoelectrically active material, transducer 119 may comprise any othermaterials configured for generating radiation and/or acoustical energy.Transducer 119 may also comprise one or more matching and/or backinglayers configured along with the transduction element 126, such as beingcoupled to the piezoelectrically active material. Transducer 119 mayalso be configured with single or multiple damping elements along thetransduction element 126.

In an embodiment, the thickness of the transduction element 126 oftransducer 119 may be configured to be uniform. That is, thetransduction element 126 may be configured to have a thickness that isgenerally substantially the same throughout.

In another embodiment, the transduction element 126 may also beconfigured with a variable thickness, and/or as a multiple dampeddevice. For example, the transduction element 126 of transducer 119 maybe configured to have a first thickness selected to provide a centeroperating frequency of a lower range, for example from approximately 1kHz to 3 MHz in one embodiment and between 15 kHz to 3 MHZ in anotherembodiment. The transduction element 126 may also be configured with asecond thickness selected to provide a center operating frequency of ahigher range, for example from approximately 3 to 100 MHz or more.

In yet another embodiment, transducer 119 may be configured as a singlebroadband transducer excited with two or more frequencies to provide anadequate output for raising the temperature within ROI 112 to thedesired level. Transducer 119 may also be configured as two or moreindividual transducers, wherein each transducer 119 may comprise atransduction element 126. The thickness of the transduction elements 126may be configured to provide center-operating frequencies in a desiredtreatment range. For example, in an embodiment, transducer 119 maycomprise a first transducer 119 configured with a first transductionelement 126A having a thickness corresponding to a center frequencyrange of approximately 1 MHz to 3 MHz, and a second transducer 119configured with a second transduction element 126B having a thicknesscorresponding to a center frequency of approximately 3 MHz to 100 MHz ormore. Various other ranges of thickness for a first and/or secondtransduction element 126 can also be realized.

Moreover, in an embodiment, any variety of mechanical lenses or variablefocus lenses, e.g. liquid-filled lenses, may also be used to focus andor defocus the energy field. For example, with reference to theembodiments depicted in FIGS. 15A and 15B, transducer 119 may also beconfigured with an electronic focusing array 124 in combination with oneor more transduction elements 126 to facilitate increased flexibility intreating ROI 12. Array 124 may be configured in a manner similar totransducer 119. That is, array 124 may be configured as an array ofelectronic apertures that may be operated by a variety of phases viavariable electronic time delays, for example, T1, T2, T3 . . . Tj. Bythe term “operated,” the electronic apertures of array 124 may bemanipulated, driven, used, and/or configured to produce and/or deliverenergy in a manner corresponding to the phase variation caused by theelectronic time delay. For example, these phase variations may be usedto deliver defocused beams, planar beams, and/or focused beams, each ofwhich may be used in combination to achieve different physiologicaleffects in ROI 112.

Transduction elements 126 may be configured to be concave, convex,and/or planar. For example, in the embodiment depicted in FIG. 15A,transduction elements 126A and 126B are configured to be concave inorder to provide focused energy for treatment of ROI 112. Additionalembodiments are disclosed in U.S. patent application Ser. No.10/944,500, entitled “System and Method for Variable Depth UltrasoundTreatment”, incorporated herein by reference in its entirety.

In another embodiment depicted in FIG. 15B, transduction elements 126Aand 126B may be configured to be substantially flat in order to providesubstantially uniform energy to ROI 112. While FIGS. 15A and 15B depictembodiments with transduction elements 126 configured as concave andsubstantially flat, respectively, transduction elements 126 may beconfigured to be concave, convex, and/or substantially flat. Inaddition, transduction elements 126 may be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element 126 may be configured to beconcave, while a second transduction element 126 may be configured to besubstantially flat.

With reference to FIGS. 15C and 15D, transducer 119 may also beconfigured as an annular array to provide planar, focused and/ordefocused acoustical energy. For example, in an embodiment, an annulararray 128 may comprise a plurality of rings 130, 132, 134 to N. Rings130, 132, 134 to N may be mechanically and electrically isolated into aset of individual elements, and may create planar, focused, or defocusedwaves. For example, such waves can be centered on-axis, such as bymethods of adjusting corresponding transmit and/or receive delays, T1,T2, T3 . . . TN. An electronic focus may be suitably moved along variousdepth positions, and may enable variable strength or beam tightness,while an electronic defocus may have varying amounts of defocusing. Inan embodiment, a lens and/or convex or concave shaped annular array 128may also be provided to aid focusing or defocusing such that any timedifferential delays can be reduced. Movement of annular array 128 inone, two or three-dimensions, or along any path, such as through use ofprobes and/or any conventional robotic arm mechanisms, may beimplemented to scan and/or treat a volume or any corresponding spacewithin ROI 112.

With reference to FIG. 15E, another transducer 119 can be configured tocomprise a spherically focused single element 136, annular/multi-element138, annular with imaging region(s) 140, line-focused single element142, 1-D linear array 144, 1-D curved (convex/concave) linear array 146,and/or 2-D array 148, with mechanical focus 150, convex lens focus 152,concave lens focus 154, compound/multiple lens focused 156, and/orplanar array form 158 to achieve focused, unfocused, or defocused soundfields for both imaging and/or therapy.

Transducer 119 may further comprise a reflective surface, tip, or areaat the end of the transducer 119 that emits ultrasound energy 121. Thisreflective surface may enhance, magnify, or otherwise change ultrasoundenergy 121 emitted from system 114.

An embodiment of a probe 118 may be suitably controlled and operated invarious manners by control system 120 as depicted in FIGS. 16A-16C whichalso relays processes images obtained by transducer 119 to display 122.In the embodiment depicted in FIGS. 16A-16C, control system 120 may becapable of coordination and control of the entire treatment process toachieve the desired therapeutic effect in tissue 11 within ROI 112. Inan embodiment, control system 120 may comprise power source components160, sensing and monitoring components 162, cooling and couplingcontrols 164, and/or processing and control logic components 166.Control system 120 may be configured and optimized in a variety of wayswith more or less subsystems and components to implement the therapeuticsystem for controlled targeting of the desired tissue 11 or subcutaneoustissue 12, and the embodiments in FIGS. 16A-16C are merely forillustration purposes.

For example, for power sourcing components 160, control system 120 maycomprise one or more direct current (DC) power supplies 168 capable ofproviding electrical energy for the entire control system 120, includingpower required by a transducer electronic amplifier/driver 170. A DCcurrent sense device 172 may also be provided to confirm the level ofpower entering amplifiers/drivers 170 for safety and monitoringpurposes, among others.

In an embodiment, amplifiers/drivers 170 may comprise multi-channel orsingle channel power amplifiers and/or drivers. In an embodiment fortransducer array configurations, amplifiers/drivers 170 may also beconfigured with a beamformer to facilitate array focusing. An beamformermay be electrically excited by an oscillator/digitally controlledwaveform synthesizer 174 with related switching logic.

Power sourcing components 160 may also comprise various filteringconfigurations 176. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 170 to increasethe drive efficiency and effectiveness. Power detection components 178may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 178may be used to monitor the amount of power entering probe 118.

Various sensing and monitoring components 162 may also be suitablyimplemented within control system 120. For example, in an embodiment,monitoring, sensing, and interface control components 180 may be capableof operating with various motion detection systems implemented withinprobe 118, to receive and process information such as acoustic or otherspatial and temporal information from ROI 112. Sensing and monitoringcomponents 162 may also comprise various controls, interfacing, andswitches 182 and/or power detectors 178. Such sensing and monitoringcomponents 162 may facilitate open-loop and/or closed-loop feedbacksystems within treatment system 114.

In an embodiment, sensing and monitoring components 162 may furthercomprise a sensor that may be connected to an audio or visual alarmsystem to prevent overuse of system 114. In this embodiment, the sensormay be capable of sensing the amount of energy transferred to the skin,and/or the time that system 114 has been actively emitting energy. Whena certain time or temperature threshold has been reached, the alarm maysound an audible alarm, or cause a visual indicator to activate to alertthe user that a threshold has been reached. This may prevent overuse ofsystem 114. In an embodiment, the sensor may be operatively connected tocontrol system 120 and force control system 20, to stop emittingultrasound energy 121 from transducer 119.

In an embodiment, a cooling/coupling control system 184 may be provided,and may be capable of removing waste heat from probe 118. Furthermorethe cooling/coupling control system 184 may be capable of providing acontrolled temperature at the superficial tissue interface and deeperinto tissue, and/or provide acoustic coupling from probe 118 to ROI 112.Such cooling/coupling control systems 184 can also be capable ofoperating in both open-loop and/or closed-loop feedback arrangementswith various coupling and feedback components.

Additionally, an embodiment of a control system 120 may further comprisea system processor and various digital control logic 186, such as one ormore of microcontrollers, microprocessors, field-programmable gatearrays, computer boards, and associated components, including firmwareand control software 188, which may be capable of interfacing with usercontrols and interfacing circuits as well as input/output circuits andsystems for communications, displays, interfacing, storage,documentation, and other useful functions. System software 188 may becapable of controlling all initialization, timing, level setting,monitoring, safety monitoring, and all other system functions requiredto accomplish user-defined treatment objectives. Further, variouscontrol switches 190 may also be suitably configured to controloperation.

With reference to FIG. 16C, an embodiment of a transducer 119 may becontrolled and operated in various manners by a hand-held format controlsystem 192. An external battery charger 194 can be used withrechargeable-type batteries 196 or the batteries can be single-usedisposable types, such as AA-sized cells. Power converters 198 producevoltages suitable for powering a driver/feedback circuit 1100 withtuning network 1102 driving transducer 119 which is coupled to thepatient via one or more acoustic coupling caps 1104. Cap 1104 can becomposed of at least one of a solid media, semi-solid e.g. gelatinousmedia, and/or liquid media equivalent to an acoustic coupling agent(contained within a housing). Cap 1104 is coupled to the patient with anacoustic coupling agent 1106. In addition, a microcontroller and timingcircuits 1108 with associated software and algorithms provide controland user interfacing via a display 1110, oscillator 1112, and otherinput/output controls 1114 such as switches and audio devices. A storageelement 1116, such as an Electrically Erasable Programmable Read-OnlyMemory (“EEPROM”), secure EEPROM, tamper-proof EEPROM, or similar deviceholds calibration and usage data. A motion mechanism with feedback 1118can be suitably controlled to scan the transducer 119, if desirable, ina line or two-dimensional pattern and/or with variable depth. Otherfeedback controls comprise a capacitive, acoustic, or other couplingdetection means and/or limiting controls 1120 and thermal sensor 1122. Acombination of the secure EEPROM with at least one of coupling caps1104, transducer 119, thermal sensor 1122, coupling detectors, or tuningnetwork may also be used. Finally, an transducer can further comprise adisposable tip 1124 that can be disposed of after contacting a patientand replaced for sanitary reasons.

With reference again to FIGS. 11-12 , an embodiment of a system 114 alsomay comprise display 122 capable of providing images of ROI 112 incertain embodiments where ultrasound energy 121 may be emitted fromtransducer 119 in a manner suitable for imaging. Display 122 may becapable of enabling the user to facilitate localization of the treatmentarea and surrounding structures, e.g., identification of subcutaneoustissue 12. In an alternative embodiment, the user may know the locationof the specific subcutaneous tissue 12 to be treated based at least inpart upon prior experience or education.

After localization, ultrasound energy 121 is delivered at a depth,distribution, timing, and energy level to achieve the desiredtherapeutic effect at ROI 112 to treat tissue 11. Before, during, and/orafter delivery of ultrasound energy 121, monitoring of the treatmentarea and surrounding structures may be conducted to further plan andassess the results and/or provide feedback to control system 120, and toa system operator via display 122. In an embodiment, localization may befacilitated through ultrasound imaging that may be used to define theposition of a desired tissue 11 in ROI 112.

For ultrasound energy 121 delivery, transducer 119 may be mechanicallyand/or electronically scanned to place treatment zones over an extendedarea in ROI 112. A treatment depth may be adjusted between a range ofapproximately 0 to 30 millimeters, and/or the greatest depth of tissue 1and/or subcutaneous tissue 12. Such delivery of energy may occur throughimaging of the targeted tissue 11, and then applying ultrasound energy121 at known depths over an extended area without initial or ongoingimaging.

The ultrasound beam from transducer 119 may be spatially and/ortemporally controlled at least in part by changing the spatialparameters of transducer 119, such as the placement, distance, treatmentdepth, and transducer 119 structure, as well as by changing the temporalparameters of transducer 119, such as the frequency, drive amplitude,and timing, with such control handled via control system 120. Suchspatial and temporal parameters may also be suitably monitored and/orutilized in open-loop and/or closed-loop feedback systems withinultrasound system 116.

Throughout this application, reference has been made to treating asingle layer of tissue 11 or subcutaneous tissue 12 at any given time.It should be noted that two or more layers of tissue may be treated atthe same time and fall within the scope of this disclosure. In certainembodiments where two or more layers of tissue are treated, muscle 13,ligaments 15, and other fibro-muscular layers of tissue can be treatedsimultaneously.

Finally, it should be noted that while this disclosure is directedprimarily to using ultrasound energy 121 to conduct proceduresnon-invasively, that the method and system for performing ablepharoplasty described above can also utilize energy such asultrasound energy 121 to assist in invasive procedures. For example,ultrasound energy 121 can be used to ablate subcutaneous tissues 12 andtissues 11 during an invasive procedure. In this regard, ultrasoundenergy 121 can be used for invasive and minimally invasive procedures.

Method and System for Treating Cartilage Tissue

With reference to FIGS. 17-24 , another method and system are providedfor treating tissue with focused, unfocused or defocused energy. In anembodiment, the energy used is ultrasound energy. In other embodiments,the energy is laser energy or radio frequency energy. In certainembodiments, the energy is ultrasound energy combined with other formsof energy such as laser or radio frequency energy. In an embodiment, theenergy used is ultrasound energy and the tissue treated is cartilagetissue. The method will be referred to as method 210 throughout. In anembodiment, the treated tissue region 21 comprises subcutaneous tissue22 and can comprise muscle, tendon, ligament or cartilage tissue (MTLC),among other types of tissue.

As depicted in the embodiment shown in FIG. 17 , method 10 broadlycomprises the following steps 2A-2D. First, at step 2A, a system thatemits energy such as ultrasound energy is provided. At step 2B, energyis applied to a Region of Interest (“ROI”) which comprises any area of abody that comprises cartilage. Certain ROIs include the nose, ears, softpalate, joint sockets such as the knee, elbow, shoulders, hips, and anyother area of the body that comprises cartilage. The energy is applieduntil a specific bio-effect is achieved at step 2C through cutting,reabsorbing or manipulating the cartilage. Certain bio-effects achievedby cutting, reabsorbing or manipulating the cartilage at step 2C cancomprise, but are not limited to, incapacitating, partiallyincapacitating, rejuvenating, ablating, micro-ablating, modifying,shortening, coagulating, paralyzing, or causing the cartilage to bereabsorbed into the body. As used throughout, the term “ablate” means todestroy or coagulate tissue at ROI 212. The term “micro-ablate” means toablate on a smaller scale. Upon the completion of bio-effects at step2C, cartilage is treated and a clinical outcome such as an otoplasty orrhinoplasty is achieved at step 2D.

In an embodiment, depicting in FIGS. 19-21 , energy such as ultrasoundenergy 221 is delivered at specific depths below a patient's skin totreat tissue 21, subcutaneous tissue 22, and cartilage 23. Certaindepths are in the range of approximately 0.1-100 millimeters. The exactdepth depends upon the location of cartilage 23 and the general locationof ROI 212. For example, an ear with relatively shallow cartilage 23 mayrequire that ultrasound energy 221 reach a depth in the range ofapproximately 50 microns to 3 millimeters.

Besides depth, ultrasound energy 221 is delivered at specificfrequencies, powers, application times, temperatures, and penetratecertain depths within ROI 212 to achieve various effects on cartilage23. Moreover, the lesion shape (when ultrasound energy 221 is applied atablative levels) also varies depending on the type of procedure beingconducted and the time ultrasound energy 221 is applied.

For example, a broad time range for applying ultrasound energy 221 isanytime time frame approximately between 1 millisecond and 10 minutes.Certain time frames include 50 milliseconds to 30 seconds to softencartilage 23 in an ear. Ablating cartilage in the ear may requireultrasound energy 221 to be applied for a longer time frame such as 100milliseconds to 5 minutes depending on the depth of cartilage 23 and thepower of ultrasound 221.

The frequency of ultrasound energy 221 can also very greatly dependingon the type and location of tissue 21 and subcutaneous tissue 22. Abroad frequency range is approximately between 1-25 MHz and rangeswithin this range can For example, to penetrate deep into the knee jointto target cartilage 23 in the knee joint may require a frequency in therange of approximately 2-8 MHz. An ear on the other hand may onlyrequire a frequency of 5-25 MHz.

In various embodiments, certain power levels to cause ablation ofcartilage 23 comprise, but are not limited to, 250 watts to 5000 watts.The temperature range to cause ablative lesions is approximately between45°−100° C. in an embodiment. However, longer time periods could be usedwith more powerful ultrasound energy or vice-versa to create ablativelesions at ROI 212.

In various embodiments, certain lesion sizes that can be produced usingmethod 210 are in the approximate range of 0.1 cubic millimeters to a1000 cubic millimeters depending on the desired result and the locationof ROI 212. For example, a smaller lesion is in the approximate range of0.1 cubic millimeters to 3 cubic millimeters. One lesion is on apatient's nose and may be in the approximate range of 5 cubicmillimeters to 1000 cubic millimeters. This type of lesion caneffectuate removing a portion of cartilage 23 from the nose.

Subcutaneous tissue 22, which may be treated by method 210, may comprisecartilage 23 and other ligament and muscle tissue. Other subcutaneoustissues 22 which may be treated may comprise various subcutaneoustissues 22, and dermis 27, muscle fascia or tissue comprisingSuperficial Muscular Aponeurotic System or “SMAS.” Subcutaneous tissue22 may be located within ROI 212 on a patient's body that may be desiredto be treated such as areas that contain cartilage 23. In variousembodiments, certain ROI 212's are the patient's ears and nose. In otherembodiments, other areas with cartilage 23 can be ROI 212. These areasinclude locations between the joints that contain cartilage 23 such asthe elbows, knees, shoulders, and any other joint. ROI 212 may furthercomprise an inner treatment region, a superficial region, a subcutaneousregion of interest and/or any other region of interest in between aninner treatment region, a superficial region, and/or any other areas.

FIG. 18 depicts certain embodiments of ROI 212's that can be treated.Energy such as ultrasound energy may be applied to the patient's ear 213and to specific regions of ear 213 such as the pinna 215. In thisembodiment, incisions 217 are created by applying energy at ablativelevels at pinna 215. Incisions 217 enable cartilage 23 that comprisespinna 215 to more easily rest backwards towards the patient's head. Inthis manner, an otoplasty procedure can be performed non-invasively.

In another similar embodiment depicted in FIG. 18 , cartilage 23 thatdefines the patient's nose 223 can be treated by method 210. In thisembodiment, energy may be applied to specific ROI 212 at nose 223 toablate cartilage 23. As depicted in this embodiment, incisions 217 arecreated by the application of energy at ablative levels. The incisionscause cartilage 23 within nose 223 to loose rigidity. This loss ofrigidity allows a surgeon or other operator to adjust nose 223. The useof method 210 can be used alone or to assist more traditional surgicaltechniques in sculpting nose 223. This enables the adjustment of nose223 and can be a substitute for a traditional nose surgery such as arhinoplasty.

In another embodiment, with reference to FIGS. 17-21 , various differentsubcutaneous tissues 22 or cartilage 23 may be treated by method 210 toproduce different bio-effects. In order to treat a specific subcutaneoustissue 22 or cartilage 23 to achieve a desired bio-effect, ultrasoundenergy 221 from system 214 may be directed to a specific depth withinROI 212 to reach the targeted subcutaneous tissue 22 or cartilage 23.For example, if it is desired to cut cartilage 23, which is 15 mm belowthe surface of the skin, ultrasound energy 221 from ultrasound system216 may be provided at ROI 212 at a level to reach up to andapproximately 15 mm below the skin (the exact depth will vary thoughdepending on the location of ROI 212) at an ablative level which may becapable of cutting cartilage 23. An example of cutting cartilage 23 isdepicted in FIG. 21 which depicts a series of lesions 227 cut intocartilage 23. Besides cutting cartilage 23, other bio-effects maycomprise incapacitating, partially incapacitating, severing,rejuvenating, removing, ablating, micro-ablating, shortening,manipulating, or removing cartilage 23 either instantly or over time,and/or other effects, and/or combinations thereof.

Depending at least in part upon the desired bio-effect and thesubcutaneous tissue 22 or cartilage 23 being treated, method 210 may beused with an extracorporeal, non-invasive, partially invasive, orinvasive procedure. Also, depending at least in part upon the specificbio-effect and subcutaneous tissue 22 targeted, there may be temperatureincreases within ROI 212 which may range approximately from 0-60° C. orany suitable range for heating, cavitation, steaming, and/orvibro-accoustic stimulation, and/or combinations thereof.

All known types of cartilage 23 can be targeted and treated according tomethod 210. Certain types of cartilage 23 comprise scaphoid cartilageand helix cartilage of an ear 213. Other types of cartilage 23 are foundin a patient's nose 223 when method 210 is used to treat cartilage 23within nose 223 as described below include, but are not necessarilylimited to, the major alar cartilage, the septal nasal cartilage, theaccessory nasal cartilage, and minor alar cartilage.

Numerous procedures to ears 213 that are typically done surgically toremove cartilage 23 from ears 213 to reduce the overall size of ears 13can also be accomplished using method 210. Certain embodiments ofprocedures include, but are not necessarily limited to, a conchal floorreduction, a conchal post wall reduction, an antihelix reduction, ascapha reduction, and a helix reduction.

In certain embodiments where cartilage 23 within ear 213 is treated withultrasound energy 221, cartilage 23 may be ablated, coagulated, andcompletely reabsorbed into the body or it can be ablated to form one ormore incisions within ear 213. In one embodiment, ear surgery such as anotoplasty is performed to adjust ears 213 which may protrude furtherfrom the patient's head than desired. The amount of protrusion of ears213 from the patient's head can be corrected by cutting cartilage 23that comprises pinna 215 of ears 213. In this embodiment, pinna 215 ofears 213 is ROI 212 and ultrasound energy 221 is used to ablate,coagulate, or cut cartilage 23 that comprises pinna 215 of ears 213.

When cartilage 23 is disposed in ears 213 or nose 223, method 210 canfurther comprise the step of utilizing a mechanical device aftertreatment to shape and form cartilage 23. For example, during aRhinoplasty, a clamp may be placed on the patient's nose 223 to helpshape nose 223 following method 210. Clamps, pins, and other mechanicaldevices can be used to shape cartilage 23 in other areas of the body toosuch as ears 213. Notably, following treatment of ears 213, mechanicalclamps or another similar device can be attached to the ears and used topush the ears in a certain direction. Once cartilage 23 has beensoftened, ablated, or otherwise affected by method 210, it is moremalleable and ears 213 are easier to force backwards (or forwards) in aparticular direction.

Different subcutaneous tissues 22 within ROI 212 may have differentacoustic properties. For example, cartilage 23 might have differentacoustic properties than muscle or fascia. These different acousticproperties affect the amount of energy applied to ROI 212 to causecertain bio-effects to cartilage 23 than may be required to achieve thesame or similar bio-effects for fascia. These acoustic properties maycomprise the varied acoustic phase velocity (speed of sound) and itspotential anisotropy, varied mass density, acoustic impedance, acousticabsorption and attenuation, target size and shape versus wavelength anddirection of incident energy, stiffness, and the reflectivity ofsubcutaneous tissues 22 such as cartilage 23, among many others.Depending on the acoustic properties of a particular subcutaneous tissue22 or cartilage 23 being treated, the application of ultrasound energy221 at ROI 212 may be adjusted to best compliment the acoustic propertyof the subcutaneous tissue 22 or cartilage 23 being targeted. Certainacoustic ranges comprise, but are not limited to, approximately 1 and 2Mrayls.

In certain embodiments of procedures, method 210 can be used forcartilage regeneration. Removing a portion of cartilage 23 from apatient will initiate cartilage regeneration in that ROI 212. In thisregard, traditionally invasive procedures that effectuate cartilage 23regeneration can be performed non-invasively using energy such asultrasound energy 221. In these embodiments, ultrasound energy 221 isapplied at ablative levels at the ROI 12 to remove a portion ofcartilage 23. Removing a portion of cartilage 23 enables cartilageregeneration to occur. One procedure that can be accomplished withcartilage regeneration is microfracture surgery.

During microfracture surgery, cartilage 23 is applied at ablative levelsto target cartilage 23 or other subcutaneous tissues 22 near cartilage23 in the knee joint. Applying ultrasound energy 221 at ablative levelsnear the knee joint causes one or more fractures in cartilage 23 orother subcutaneous tissue 22 such as bones. When bones or othersubcutaneous tissues 22 are targeted, sufficient ultrasound energy 221is applied to ablate those tissues. These fractures result in cartilage23 re-growing in the place of the ablated subcutaneous tissues 22 and anon-invasive microfracture surgery is performed.

In another embodiment, cartilage 23 between the joints is treated withmethod 210. In this regard, swollen or otherwise injured cartilage 23responsible for osteoarthritis, rheumatoid arthritis, and juvenilerheumatoid arthritis can be treated with method 210. For example, ROI212 may be along a patient's knees to treat cartilage 23 that serves asa cushion in a patient's knee socket. Alternatively, ROI 212 can bedisposed on a patient's shoulder area to treat cartilage 23 disposed onthe shoulder joint. In these embodiments, ultrasound energy 221 may notbe applied at ablative levels, e.g., between 250 watts to 5000 watts attemperatures between 45° C. to 100° C., but at levels that produceenough heat at ROI 212 to reduce swelling and the size of cartilage 23within these joints.

In yet another embodiment, cartilage, muscle, and other tissueresponsible for snoring and/or sleep apnea are treated by method 210.These tissues are typically located in and around the hard palate andthe soft palate. In this embodiment, cartilage 23, and other MTLC tissueare treated with ultrasound energy 221 at ablative levels to bedestroyed or reabsorbed into the body and thus unblock restrictedairways that are responsible for snoring and/or sleep apnea. In oneembodiment, transducer 219 is placed on the exterior of patient's bodyto treat ROI 212 at the neck around the Adam's apple. In anotherembodiment, transducer 219 is configured to be inserted within the oralcavity at the patient's mouth and to treat cartilage 23 and other MTLCtissue internally.

In another embodiment, method 210 can be used to assist in delivery ofvarious fillers and other medicines to ROI 212. According to thisembodiment, ultrasound energy 221 assists in forcing the fillers andmedicants into tissue 21 and subcutaneous tissue 22 at ROI 12.Hyaluronic acid can be delivered to ROI 212 in this manner. Theapplication of ultrasound energy 221 to ROI 212 causes surroundingtissues to absorb the fillers such as hyaluronic acid by increasing thetemperature at ROI 212 and through the mechanical effects of ultrasoundsuch as cavitation and streaming. Utilizing ultrasound energy 221 toeffectuate the delivery of medicants and fillers is described in U.S.patent application Ser. No. 11/163,177 entitled “Method and System forTreating Acne and Sebaceous Glands” which is incorporated by referencein its entirety.

As depicted in the embodiment of the system shown in FIG. 22 , a system214 used for method 210 is an ultrasound system 216 that may be capableof emitting ultrasound energy 221 that is focused, unfocused ordefocused to treat cartilage 23 at ROI 212. System 214 may comprise aprobe 218, a control system 220, and a display 222. System 214 may beused to delivery energy to, and monitor ROI 212. Certain embodiments ofsystems are disclosed in U.S. patent application Ser. No. 11/163,177entitled “Method and System for Treating Acne and Sebaceous Glands,”U.S. patent application Ser. No. 10/950,112 entitled “Method and Systemfor Combined Ultrasound Treatment”, and U.S. Patent Application No.60/826,039 entitled “Method and System for Non-Ablative Acne Treatment”,each of which are hereby incorporated by reference in its entirety.

With additional reference to FIGS. 23A-23E, an embodiment of a probe 218may be a transducer 219 capable of emitting ultrasound energy 221 intoROI 212. This may heat ROI 212 at a specific depth to target a specifictissue 21 or cartilage 23 causing that tissue 21 or cartilage 23 to beincapacitated, partially incapacitated, rejuvenated, ablated, modified,micro-ablated, shortened, coagulated, paralyzed, or reabsorbed into thebody. A coupling gel may be used to couple probe 218 to ROI 212.Ultrasound energy 221 may be emitted in various energy fields in thisembodiment. With additional reference to FIG. 23A and FIG. 23B, theenergy fields may be focused, defocused, and/or made substantiallyplanar by transducer 219, to provide many different effects. Energy maybe applied in a C-plane or C-scan. For example, in one embodiment, agenerally substantially planar energy field may provide a heating and/orpretreatment effect, a focused energy field may provide a moreconcentrated source of heat or hypothermal effect, and a non-focusedenergy field may provide diffused heating effects. It should be notedthat the term “non-focused” as used throughout encompasses energy thatis unfocused or defocused. Further, in one embodiment (as depicted inFIG. 19 ) the application of ultrasound energy may provide imaging orROI 212.

With continued reference to FIGS. 23A and 23B, transducer 219 maycomprise one or more transducers for facilitating treatment. Transducer219 may further comprise one or more transduction elements 226, e.g.,elements 226A or 226B. The transduction elements 226 may comprisepiezoelectrically active material, such as lead zirconante titanate(PZT), or other piezoelectrically active material such as, but notlimited to, a piezoelectric ceramic, crystal, plastic, and/or compositematerials, as well as lithium niobate, lead titanate, barium titanate,and/or lead metaniobate. In addition to, or instead of, apiezoelectrically active material, transducer 219 may comprise any othermaterials configured for generating radiation and/or acoustical energy.Transducer 219 may also comprise one or more matching and/or backinglayers configured along with the transduction element 226, such as beingcoupled to the piezoelectrically active material. Transducer 219 mayalso be configured with single or multiple damping elements along thetransduction element 226.

In an embodiment, the thickness of the transduction element 226 oftransducer 219 may be configured to be uniform. That is, thetransduction element 226 may be configured to have a thickness that isgenerally substantially the same throughout.

As depicted in the embodiment shown in FIGS. 23A and 23B, transductionelement 226 may also be configured with a variable thickness, and/or asa multiple damped device. For example, the transduction element 226 oftransducer 219 may be configured to have a first thickness selected toprovide a center operating frequency of a lower range, for example fromapproximately 1 kHz to 3 MHz. The transduction element 226 may also beconfigured with a second thickness selected to provide a centeroperating frequency of a higher range, for example from approximately 3to 100 MHz or more.

In yet another embodiment, transducer 19 may be configured as a singlebroadband transducer excited with two or more frequencies to provide anadequate output for raising the temperature within ROI 212 to thedesired level. Transducer 219 may also be configured as two or moreindividual transducers, wherein each transducer 219 may comprise atransduction element 226. The thickness of the transduction elements 226may be configured to provide center-operating frequencies in a desiredtreatment range. For example, in an embodiment, transducer 219 maycomprise a first transducer 219 configured with a first transductionelement 226A having a thickness corresponding to a center frequencyrange of approximately 1 MHz to 3 MHz, and a second transducer 19configured with a second transduction element 226B having a thicknesscorresponding to a center frequency of approximately 3 MHz to 100 MHz ormore. Various other ranges of thickness for a first and/or secondtransduction element 226 can also be realized.

Moreover, any variety of mechanical lenses or variable focus lenses,e.g. liquid-filled lenses, may also be used to focus and or defocus theenergy field. For example, with reference to FIGS. 23A and 23B,transducer 219 may also be configured with an electronic focusing array224 in combination with one or more transduction elements 226 tofacilitate increased flexibility in treating ROI 212. Array 224 may beconfigured in a manner similar to transducer 219. That is, array 224 maybe configured as an array of electronic apertures that may be operatedby a variety of phases via variable electronic time delays, for example,T1, T2, T3 . . . Tj. By the term “operated,” the electronic apertures ofarray 224 may be manipulated, driven, used, and/or configured to produceand/or deliver energy in a manner corresponding to the phase variationcaused by the electronic time delay. For example, these phase variationsmay be used to deliver defocused beams, planar beams, and/or focusedbeams, each of which may be used in combination to achieve differentphysiological effects in ROI 212.

Transduction elements 226 may be configured to be concave, convex,and/or planar. For example, as depicted in FIG. 23A, transductionelements 226A and 226B are configured to be concave in order to providefocused energy for treatment of ROI 212. Additional embodiments aredisclosed in U.S. patent application Ser. No. 10/944,500, entitled“System and Method for Variable Depth Ultrasound Treatment”,incorporated herein by reference in its entirety.

In another embodiment, depicted in FIG. 23B, transduction elements 226Aand 226B may be configured to be substantially flat in order to providesubstantially uniform energy to ROI 212. While FIGS. 23A and 23B depictembodiments with transduction elements 226 configured as concave andsubstantially flat, respectively, transduction elements 226 may beconfigured to be concave, convex, and/or substantially flat. Inaddition, transduction elements 226 may be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element 226 may be configured to beconcave, while a second transduction element 226 may be configured to besubstantially flat.

Moreover, transduction element 226 can be any distance from thepatient's skin. In that regard, it can be far away from the skindisposed within a long transducer or it can be just a few millimetersfrom the surface of the patient's skin. In certain embodiments,positioning the transduction element 26 closer to the patient's skin isbetter for emitting ultrasound at high frequencies. Moreover, both threeand two dimensional arrays of elements can be used in the presentinvention.

With reference to FIGS. 23C and 23D, transducer 219 may also beconfigured as an annular array to provide planar, focused and/ordefocused acoustical energy. For example, in an embodiment, an annulararray 228 may comprise a plurality of rings 230, 232, 234 to N. Rings230, 232, 234 to N may be mechanically and electrically isolated into aset of individual elements, and may create planar, focused, or defocusedwaves. For example, such waves can be centered on-axis, such as bymethods of adjusting corresponding transmit and/or receive delays, T1,T2, T3 . . . TN. An electronic focus may be suitably moved along variousdepth positions, and may enable variable strength or beam tightness,while an electronic defocus may have varying amounts of defocusing. Inan embodiment, a lens and/or convex or concave shaped annular array 228may also be provided to aid focusing or defocusing such that any timedifferential delays can be reduced. Movement of annular array 228 inone, two or three-dimensions, or along any path, such as through use ofprobes and/or any conventional robotic arm mechanisms, may beimplemented to scan and/or treat a volume or any corresponding spacewithin ROI 212.

With reference to FIG. 23E, another transducer 219 can be configured tocomprise a spherically focused single element 236, annular/multi-element238, annular with imaging region(s) 240, line-focused single element242, 1-D linear array 244, 1-D curved (convex/concave) linear array 246,and/or 2-D array 248, with mechanical focus 250, convex lens focus 252,concave lens focus 254, compound/multiple lens focused 256, and/orplanar array form 258 to achieve focused, unfocused, or defocused soundfields for both imaging and/or therapy.

Transducer 219 may further comprise a reflective surface, tip, or areaat the end of the transducer 219 that emits ultrasound energy 221. Thisreflective surface may enhance, magnify, or otherwise change ultrasoundenergy 221 emitted from system 214.

In an embodiment, suction is used to attach probe 218 to the patient'sbody. In this embodiment, a negative pressure differential is createdand probe 218 attaches to the patient's skin by suction. A vacuum-typedevice is used to create the suction and the vacuum device can beintegral with, detachable, or completely separate from probe 218. Thesuction attachment of probe 18 to the skin and associated negativepressure differential ensures that probe 18 is properly coupled to thepatient's skin. Further, the suction-attachment also reduces thethickness of the tissue to make it easier to reach the targeted tissue.In other embodiments, a coupling gel is used to couple probe 218 to thepatient's skin. The coupling gel can include medicines and other drugsand the application of ultrasound energy 221 can facilitate transdermaldrug delivery.

Turning now to FIGS. 24A-24C, an probe 218 may be suitably controlledand operated in various manners by control system 220 which also relaysprocesses images obtained by transducer 219 to display 222. Controlsystem 220 may be capable of coordination and control of the entiretreatment process to achieve the desired therapeutic effect on tissue 21within ROI 212. In an embodiment, control system 220 may comprise powersource components 260, sensing and monitoring components 262, coolingand coupling controls 264, and/or processing and control logiccomponents 266. Control system 220 may be configured and optimized in avariety of ways with more or less subsystems and components to implementthe therapeutic system for controlled targeting of the desired tissue21, and the embodiments in FIGS. 24A-24C are merely for illustrationpurposes.

For example, for power sourcing components 260, control system 220 maycomprise one or more direct current (DC) power supplies 268 capable ofproviding electrical energy for entire control system 220, includingpower required by a transducer electronic amplifier/driver 270. A DCcurrent sense device 272 may also be provided to confirm the level ofpower entering amplifiers/drivers 270 for safety and monitoringpurposes, among others.

In an embodiment, amplifiers/drivers 270 may comprise multi-channel orsingle channel power amplifiers and/or drivers. In an embodiment fortransducer array configurations, amplifiers/drivers 270 may also beconfigured with a beamformer to facilitate array focusing. An beamformermay be electrically excited by an oscillator/digitally controlledwaveform synthesizer 274 with related switching logic.

Power sourcing components 260 may also comprise various filteringconfigurations 276. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 270 to increasethe drive efficiency and effectiveness. Power detection components 278may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 278may be used to monitor the amount of power entering probe 218.

Various sensing and monitoring components 262 may also be suitablyimplemented within control system 220. For example, in an embodiment,monitoring, sensing, and interface control components 280 may be capableof operating with various motion detection systems implemented withinprobe 218, to receive and process information such as acoustic or otherspatial and temporal information from ROI 212. Sensing and monitoringcomponents 262 may also comprise various controls, interfacing, andswitches 282 and/or power detectors 278. Such sensing and monitoringcomponents 262 may facilitate open-loop and/or closed-loop feedbacksystems within treatment system 214.

In an embodiment, sensing and monitoring components 262 may furthercomprise a sensor that may be connected to an audio or visual alarmsystem to prevent overuse of system 214. In this embodiment, the sensormay be capable of sensing the amount of energy transferred to the skin,and/or the time that system 214 has been actively emitting energy. Whena certain time or temperature threshold has been reached, the alarm maysound an audible alarm, or cause a visual indicator to activate to alertthe user that a threshold has been reached. This may prevent overuse ofthe system 214. In an embodiment, the sensor may be operativelyconnected to control system 220 and force control system 220, to stopemitting ultrasound energy 221 from transducer 219.

In an embodiment, a cooling/coupling control system 284 may be provided,and may be capable of removing waste heat from probe 218. Furthermorethe cooling/coupling control system 284 may be capable of providing acontrolled temperature at the superficial tissue interface and deeperinto tissue, and/or provide acoustic coupling from probe 218 to ROI 212.Such cooling/coupling control systems 284 can also be capable ofoperating in both open-loop and/or closed-loop feedback arrangementswith various coupling and feedback components.

Additionally, an control system 220 may further comprise a systemprocessor and various digital control logic 286, such as one or more ofmicrocontrollers, microprocessors, field-programmable gate arrays,computer boards, and associated components, including firmware andcontrol software 288, which may be capable of interfacing with usercontrols and interfacing circuits as well as input/output circuits andsystems for communications, displays, interfacing, storage,documentation, and other useful functions. System software 288 may becapable of controlling all initialization, timing, level setting,monitoring, safety monitoring, and all other system functions requiredto accomplish user-defined treatment objectives. Further, variouscontrol switches 290 may also be suitably configured to controloperation.

With reference to FIG. 24C, an transducer 219 may be controlled andoperated in various manners by a hand-held format control system 292. Anexternal battery charger 294 can be used with rechargeable-typebatteries 296 or the batteries can be single-use disposable types, suchas AA-sized cells. Power converters 298 produce voltages suitable forpowering a driver/feedback circuit 2100 with tuning network 2102 drivingtransducer 219 coupled to the patient via one or more acoustic couplingcaps 2104. The cap 2104 can be composed of at least one of a solidmedia, semi-solid e.g. gelatinous media, and/or liquid media equivalentto an acoustic coupling agent (contained within a housing). The cap 2104is coupled to the patient with an acoustic coupling agent 2106. Inaddition, a microcontroller and timing circuits 2108 with associatedsoftware and algorithms provide control and user interfacing via adisplay 2110, oscillator 2112, and other input/output controls 2114 suchas switches and audio devices. A storage element 2116, such as anElectrically Erasable Programmable Read-Only Memory (“EEPROM”), secureEEPROM, tamper-proof EEPROM, or similar device holds calibration andusage data in an embodiment. A motion mechanism with feedback 118 can besuitably controlled to scan the transducer 219, if desirable, in a lineor two-dimensional pattern and/or with variable depth. Other feedbackcontrols comprises a capacitive, acoustic, or other coupling detectionmeans and/or limiting controls 2120 and thermal sensor 2122. Acombination of the secure EEPROM with at least one of coupling caps2104, transducer 219, thermal sensor 2122, coupling detectors, or tuningnetwork. Finally, an transducer can further comprise a disposable tip2124 that can be disposed of after contacting a patient and replaced forsanitary reasons.

With reference again to FIGS. 19 and 22 , an system 214 also maycomprise display 222 capable of providing images of the ROI 212 incertain embodiments where ultrasound energy 221 may be emitted fromtransducer 219 in a manner suitable for imaging. Display 222 may becapable of enabling the user to facilitate localization of the treatmentarea and surrounding structures, e.g., identification of MLTC tissue. Inthese embodiments, the user can observe the effects to cartilage 23 inreal-time as they occur. Therefore, the user can see the size of lesionswithin cartilage 23 created or the amount of cartilage 23 ablated andensure that the correct amount of cartilage 23 is treated. In analternative embodiment, the user may know the location of the specificMLTC tissue to be treated based at least in part upon prior experienceor education.

After localization, ultrasound energy 221 is delivered at a depth,distribution, timing, and energy level to achieve the desiredtherapeutic effect at ROI 12 to treat cartilage 23. Before, duringand/or after delivery of ultrasound energy 221, monitoring of thetreatment area and surrounding structures may be conducted to furtherplan and assess the results and/or providing feedback to control system220, and to a system operator via display 222. In an embodiment,localization may be facilitated through ultrasound imaging that may beused to define the position of cartilage 23 in ROI 212.

For ultrasound energy 221 delivery, transducer 219 may be mechanicallyand/or electronically scanned to place treatment zones over an extendedarea in ROI 212. A treatment depth may be adjusted between a range ofapproximately 1 to 30 millimeters, and/or the greatest depth ofsubcutaneous tissue 22 or cartilage 23 being treated. Such delivery ofenergy may occur through imaging of the targeted cartilage 23, and thenapplying ultrasound energy 221 at known depths over an extended areawithout initial or ongoing imaging.

In certain embodiments, the delivery of ultrasound energy 221 to ROI 212may be accomplished by utilizing specialized tools that are designed fora specific ROI 212. For example, if ROI 212 comprises cartilage 23within the ear, a specialized tool that further comprises transducer 219configured to fit within the patient's ear can be used. In thisembodiment, the transducer 219 is attached to a probe, package, oranother device configured to easily fit within a patient's ear canal anddeliver ultrasound energy 221 to the ear. Similarly, other types ofprobes 219 or equipment can be utilized to deliver ultrasound energy 221to a patient's nose of if cartilage 23 is located within or comprisesthe nose. In these embodiments, transducer 219 is configured to beinserted within the nasal orifice or the ear canal.

The ultrasound beam from transducer 219 may be spatially and/ortemporally controlled at least in part by changing the spatialparameters of transducer 219, such as the placement, distance, treatmentdepth and transducer 219 structure, as well as by changing the temporalparameters of transducer 219, such as the frequency, drive amplitude,and timing, with such control handled via control system 220. Suchspatial and temporal parameters may also be suitably monitored and/orutilized in open-loop and/or closed-loop feedback systems withinultrasound system 216.

Finally, it should be noted that while this disclosure is directedprimarily to using ultrasound energy 221 to conduct proceduresnon-invasively, that the method and system for treating cartilagedescribed above can also utilize energy such as ultrasound energy 221 toassist in invasive procedures. For example, ultrasound energy 221 can beused to ablate subcutaneous tissues 22 and tissues 21 during an invasiveprocedure. In this regard, ultrasound energy 221 can be used forinvasive or minimally invasive procedures.

Present embodiments may be described herein in terms of variousfunctional components and processing steps. It should be appreciatedthat such components and steps may be realized by any number of hardwarecomponents configured to perform the specified functions. For example,other embodiments may employ various medical treatment devices, visualimaging and display devices, input terminals and the like, which maycarry out a variety of functions under the control of one or morecontrol systems or other control devices. In addition, embodiments maybe practiced in any number of medical contexts and that the embodimentsrelating to a system as described herein are merely indicative ofapplications for the disclosed subject matter. For example, theprinciples, features and methods discussed may be applied to any medicalapplication. Further, various aspects of the present disclosure may besuitably applied to other applications, such as other medical orindustrial applications.

In various embodiments, the different numbers of removable transducermodules can be configured for different or variable ultrasonicparameters. For example, in various non-limiting embodiments, theultrasonic parameter can relate to transducer geometry, size, timing,spatial configuration, frequency, variations in spatial parameters,variations in temporal parameters, coagulation formation, controllednecrosis areas or zones, depth, width, absorption coefficient,refraction coefficient, tissue depths, and/or other tissuecharacteristics. In various embodiments, a variable ultrasonic parametermay be altered, or varied, in order to effect the formation of a lesionfor the desired cosmetic approach. In various embodiments, a variableultrasonic parameter may be altered, or varied, in order to effect theformation of a lesion for the desired clinical approach. By way ofexample, one variable ultrasonic parameter relates to aspects ofconfigurations associated with tissue depth. For example, somenon-limiting embodiments of removable transducer modules can beconfigured for a tissue depth of 1 mm, 1.5 mm, 2 mm, 3 mm, 4.5 mm, 6 mm,less than 3 mm, between 3 mm and 4.5 mm, more than more than 4.5 mm,more than 6 mm, and anywhere in the ranges of 0-3 mm, 0-4.5 mm, 0-25 mm,0-100 mm, and any depths therein. In one embodiment, an ultrasonicsystem is provided with two transducer modules, in which the firstmodule applies treatment at a depth of about 4.5 mm and the secondmodule applies treatment at a depth of about 3 mm. An optional thirdmodule that applies treatment at a depth of about 1.5-2 mm is alsoprovided. In some embodiments, a system and/or method comprises the useof removable transducers that treat at different depths is provided(e.g., a first depth in the range of about 1-4 mm below the skin surfaceand a second depth at about 4-7 mm below the skin surface). Acombination of two or more treatment modules is particularlyadvantageous because it permits treatment of a patient at varied tissuedepths, thus providing synergistic results and maximizing the clinicalresults of a single treatment session. For example, treatment atmultiple depths under a single surface region permits a larger overallvolume of tissue treatment, which results in enhanced collagen formationand tightening. Additionally, treatment at different depths affectsdifferent types of tissue, thereby producing different clinical effectsthat together provide an enhanced overall cosmetic result. For example,superficial treatment may reduce the visibility of wrinkles and deepertreatment may induce formation of more collagen growth. In someembodiments, treatment of different depths is used to treat differentlayers of tissue, e.g., epidermal tissue, the superficial dermal tissue,the mid-dermal tissue, and the deep dermal tissue. In anotherembodiment, treatment at different depths treats different cell types(e.g., dermal cells, fat cells). The combined treatment of differentcell types, tissue types or layers, in, for example, a singletherapeutic session, are advantageous in several embodiments.

Although treatment of a subject at different depths in one session maybe advantageous in some embodiments, sequential treatment over time maybe beneficial in other embodiments. For example, a subject may betreated under the same surface region at one depth in week 1, a seconddepth in week 2, etc. The new collagen produced by the first treatmentmay be more sensitive to subsequent treatments, which may be desired forsome indications. Alternatively, multiple depth treatment under the samesurface region in a single session may be advantageous because treatmentat one depth may synergistically enhance or supplement treatment atanother depth (due to, for example, enhanced blood flow, stimulation ofgrowth factors, hormonal stimulation, etc.).

In several embodiments, different transducer modules provide treatmentat different depths. In several embodiments, a system comprisingdifferent transducers, each having a different depth, is particularlyadvantageous because it reduces the risk that a user will inadvertentlyselect an incorrect depth. In one embodiment, a single transducer modulecan be adjusted or controlled for varied depths. Safety features tominimize the risk that an incorrect depth will be selected can be usedin conjunction with the single module system.

In several embodiments, a method of treating the lower face and neckarea (e.g., the submental area) is provided. In several embodiments, amethod of treating (e.g., softening) mentolabial folds is provided. Inother embodiments, a method of blepharoplasty and/or treating the eyeregion is provided. Upper lid laxity improvement and periorbital linesand texture improvement will be achieved by several embodiments bytreating at variable depths. In one embodiment, a subject is treatedwith about 40-50 lines at depths of 4.5 and 3 mm. The subject isoptionally treated with about 40-50 lines at a depth of about 1.5-2 mm.The subject is optionally treated with about 40-50 lines at a depth ofabout 6 mm. By treating at varied depths in a single treatment session,optimal clinical effects (e.g., softening, tightening) can be achieved.

In several embodiments, the treatment methods described herein arenon-invasive cosmetic procedures. In some embodiments, the methods canbe used in conjunction with invasive procedures, such as surgicalfacelifts or liposuction, where skin tightening is desired. In severalembodiments, the systems and methods described herein do not cavitate orproduce shock waves. In one embodiment, treatment destroys fat cells,while leaving other types of tissue intact. In some embodiments, coolingis not necessary and not used. In some embodiments, cell necrosis ispromoted (rather than reduced) via ablation. In some embodiments,treatment does not irritate or scar a dermis layer, but instead affectstissue subdermally. In several embodiments, the transducer has a singleemitter. In other embodiments, a plurality of emitters is used. Inseveral embodiments, treatment is performed without puncturing the skin(e.g., with needles) and without the need to suction, pinch or vacuumtissue. In other embodiments, suctioning, pinching or vacuuming isperformed. In several embodiments, the lesions that are formed do notoverlap. In several embodiments, the treatment employs a pulse durationof 10-60 milliseconds (e.g., about 20 milliseconds) and emits betweenabout 1,000-5,000 W/cm² (e.g., 2,500 W/cm²). In several embodiments, theenergy flux is about 1.5-5.0 J/cm². In several embodiments, efficacy isproduced using 20-500 lines of treatment (e.g., 100-250 lines). In oneembodiment, each line takes about 0.5 to 2 seconds to deliver. In oneembodiment, each line contains multiple individual lesions which may ormay not overlap.

In one embodiment, an transducer module is configured with a treatmentfrequency of approximately 4 MHz, a treatment depth of approximately 4.5mm and an imaging depth range of roughly 0-8 mm. In various embodiments,the treatment frequencies can be in the range of 4-5 MHz, 4.2-4.9 MHz,4.3-4.7 MHz, 4.3 MHz, 4.7 MHz, or other frequencies. In variousembodiments, the treatment depth can be in the range of approximately4-5 mm, 4.3 mm-4.7 mm, and/or 4.4 mm-4.6 mm. In one embodiment, anemitter-receiver module 200 is configured with a treatment frequency ofapproximately 7 MHz, a treatment depth of approximately 3.0 mm and animaging depth range of roughly 0-8 mm. In various embodiments, thetreatment frequencies can be in the range of 7-8 MHz, 7.2-7.8 MHz,7.3-7.7 MHz, 7.3 MHz, 477 MHz, 7.5 MHz, or other frequencies. In variousembodiments, the treatment depth can be in the range of approximately4-5 mm, 4.3 mm-4.7 mm, and/or 4.4 mm-4.6 mm. In one embodiment,transducer module is configured with a treatment frequency ofapproximately 7 MHz, a treatment depth of approximately 4.5 mm and animaging depth range of roughly 0-8 mm. In various embodiments, thetreatment frequencies can be in the range of 7-8 MHz, 7.2-7.8 MHz,7.3-7.7 MHz, 7.3 MHz, 477 MHz, 7.5 MHz, or other frequencies. In variousembodiments, the treatment depth can be in the range of approximately4-5 mm, 4.3 mm-4.7 mm, and/or 4.4 mm-4.6 mm.

Various embodiments of the system can comprise a radio frequency(hereinafter “RF”) driver circuit which can deliver and/or monitor powergoing to the transducer. In one embodiment, a therapy subsystem cancontrol an acoustic power of the transducer. In one embodiment, theacoustic power can be from a range of 1 watt (hereinafter “W”) to about100 W in a frequency range from about 1 MHz to about 10 MHz, or fromabout 10 W to about 50 W at a frequency range from about 3 MHz to about8 MHz. In one embodiment, the acoustic power and frequencies are about40 W at about 4.3 MHz and about 30 W at about 7.5 MHz. An acousticenergy produced by this acoustic power can be between about 0.01 joule(hereinafter “J”) to about 10 J or about 2 J to about 5 J. In oneembodiment, the acoustic energy is in a range less than about 3 J. Invarious embodiments, the acoustic energy is approximately 0.2 J-2.0 J,0.2 J, 0.4 J, 1.2 J, 2.0 J or other values. In one embodiment, theamount of energy deliverable is adjustable.

In various embodiments the system can control a time on for thetransducer. In one embodiment, the time on can be from about 1millisecond (hereinafter “ms”) to about 100 ms or about 10 ms to about50 ms. In one embodiment, time on periods can be about 30 ms for a 4.3MHz emission and about 30 ms for a 7.5 MHz emission.

Embodiments of the present invention may be described herein in terms ofvarious functional components and processing steps. It should beappreciated that such components and steps may be realized by any numberof hardware components configured to perform the specified functions.For example, embodiments of the present invention may employ variousmedical treatment devices, visual imaging and display devices, inputterminals and the like, which may carry out a variety of functions underthe control of one or more control systems or other control devices. Inaddition, embodiments of the present invention may be practiced in anynumber of medical contexts and that some embodiments relating to amethod and system for noninvasive face lift and deep tissue tighteningas described herein are merely indicative of some applications for theinvention. For example, the principles, features and methods discussedmay be applied to any tissue, such as in one embodiment, a SMAS-likemuscular fascia, such as platysma, temporal fascia, and/or occipitalfascia, or any other medical application.

Further, various aspects of embodiments of the present invention may besuitably applied to other applications. Some embodiments of the systemand method of the present invention may also be used for controlledthermal injury of various tissues and/or noninvasive facelifts and deeptissue tightening. Certain embodiments of systems and methods aredisclosed in U.S. patent application Ser. No. 12/028,636 filed Feb. 8,2008 to which priority is claimed and which is incorporated herein byreference in its entirety, along with each of applications to which itclaims priority. Certain embodiments of systems and methods forcontrolled thermal injury to various tissues are disclosed in U.S.patent application Ser. No. 11/163,148 filed on Oct. 5, 2005 to whichpriority is claimed and which is incorporated herein by reference in itsentirety as well as the provisional application to which thatapplication claims priority to (U.S. Provisional Application No.60/616,754 filed on Oct. 6, 2004). Certain embodiments of systems andmethods for non-invasive facelift and deep tissue tightening aredisclosed in U.S. patent application Ser. No. 11/163,151 filed on Oct.6, 2005, to which priority is claimed and which is incorporated hereinby reference in its entirety as well as the provisional application towhich that application claims priority to (U.S. Provisional ApplicationNo. 60/616,755 filed on Oct. 6, 2004).

In accordance with some embodiments of the present invention, a methodand system for noninvasive face lifts and deep tissue tightening areprovided. For example, in accordance with an embodiment, with referenceto FIG. 25 , a treatment system 2100 (or otherwise referred to as acosmetic treatment system or CTS) configured to treat a region ofinterest 2106 (or otherwise referred to as a treatment zone) comprises acontrol system 2102 (or otherwise referred to as a control module orcontrol unit), an imaging/therapy probe with acoustic coupling 2104 (orotherwise referred to as a probe, probe system, hand wand,emitter/receiver module, removable transducer module), and a displaysystem 2108 (or otherwise referred to as display or interactivegraphical display). Control system 2102 and display system 2108 cancomprise various configurations for controlling probe 2102 and overallsystem 2100 functionality, such as, for example, a microprocessor withsoftware and a plurality of input/output devices, system and devices forcontrolling electronic and/or mechanical scanning and/or multiplexing oftransducers, a system for power delivery, systems for monitoring,systems for sensing the spatial position of the probe and/ortransducers, and/or systems for handling user input and recordingtreatment results, among others. Imaging/therapy probe 2104 can comprisevarious probe and/or transducer configurations. For example, probe 2104can be configured for a combined dual-mode imaging/therapy transducer,coupled or co-housed imaging/therapy transducers, or simply a separatetherapy probe and an imaging probe.

In accordance with an embodiment, treatment system 2100 is configuredfor treating tissue above, below and/or in the SMAS region by first,imaging of region of interest 2106 for localization of the treatmentarea and surrounding structures, second, delivery of ultrasound energyat a depth, distribution, timing, and energy level to achieve thedesired therapeutic effect, and third to monitor the treatment areabefore, during, and after therapy to plan and assess the results and/orprovide feedback. According to another embodiment of the presentinvention, treatment system 2100 is configured for controlled thermalinjury of human superficial tissue based on treatment system 2100'sability to controllably create thermal lesions of conformally variableshape, size, and depth through precise spatial and temporal control ofacoustic energy deposition.

As to the treatment of the SMAS region (or SMAS 507), connective tissuecan be permanently tightened by thermal treatment to temperatures about60 degrees Celsius or higher. Upon ablating, collagen fibers shrinkimmediately by approximately 30% of their length. The shrunken fiberscan produce tightening of the tissue, wherein the shrinkage should occuralong the dominant direction of the collagen fibers. Throughout thebody, collagen fibers are laid down in connective tissues along thelines of chronic stress (tension). On the aged face, neck and/or body,the collagen fibers of the SMAS region are predominantly oriented alongthe lines of gravitational tension. Shrinkage of these fibers results intightening of the SMAS in the direction desired for correction of laxityand sagging due to aging. The treatment comprises the ablation ofspecific regions of the SMAS region and similar suspensory connectivetissues.

In addition, the SMAS region varies in depth and thickness at differentlocations, e.g., between 0.5 mm to 5 mm or more. On the face and otherparts of the body, important structures such as nerves, parotid gland,arteries and veins are present over, under or near the SMAS region.Tightening of the SMAS in certain locations, such as the preauricularregion associated with sagging of the cheek to create jowls, the frontalregion associated with sagging brows, mandibular region associated withsagging neck, can be conducted. Treating through localized heating ofregions of the SMAS or other suspensory subcutaneous connective tissuestructures to temperatures of about 60-90° C., without significantdamage to overlying or distal/underlying tissue, i.e., proximal tissue,as well as the precise delivery of therapeutic energy to SMAS regions,and obtaining feedback from the region of interest before, during, andafter treatment can be suitably accomplished through treatment system2100.

To further illustrate an embodiments of a method and system 2200, withreference to FIGS. 26A-26F, imaging of a region of interest 2206, suchas by imaging a region 2222 and displaying images 2224 of the region ofinterest 2206 on a display 2208, to facilitate localization of thetreatment area and surrounding structures can initially be conducted.Next, delivery of ultrasound energy 2220 at a suitably depth,distribution, timing, and energy level to achieve the desiredtherapeutic effect of thermal injury or ablation to treat SMAS region2216 (or otherwise referred to as SMAS) can be suitably provided byprobe 2204 (or otherwise referred to as module, or emitter-receivermodule) through control by control system 2202. Monitoring of thetreatment area and surrounding structures before, during, and aftertherapy, i.e., before, during, and after the delivery of ultrasoundenergy to SMAS region 2216, can be provided to plan and assess theresults and/or provide feedback to control system 2202 and a systemuser.

Ultrasound imaging and providing of images 2224 can facilitate safetargeting of the SMAS layer 2216. For example, with reference to FIG.26B, specific targeting for the delivery of energy can be betterfacilitated to avoid heating vital structures such as the facial nerve(motor nerve) 2234, parotid gland (which makes saliva) 2236, facialartery 2238, and trigeminal nerve (for sensory functions) 2232 amongother regions. Further, use of imaging with targeted energy delivery toprovide a limited and controlled depth of treatment can minimize thechance of damaging deep structures, such as for example, the facialnerve that lies below the parotid, which is typically 10 mm thick.

In accordance with an embodiment, with reference to FIG. 26C, ultrasoundimaging of region 2222 of the region of interest 2206 can also be usedto delineate SMAS layer 2216 as the superficial, echo-dense layeroverlying facial muscles 2218. Such muscles can be seen via imagingregion 2222 by moving muscles 2218, for example by extensional flexingof muscle layer 2218 generally towards directions 2250 and 2252. Suchimaging of region 2222 may be further enhanced via signal and imageprocessing. Once SMAS layer 2216 is localized and/or identified, SMASlayer 2216 is ready for treatment.

The delivery of ultrasound energy 2220 at a suitably depth,distribution, timing, and energy level is provided by probe 2204 throughcontrolled operation by control system 2202 to achieve the desiredtherapeutic effect of thermal injury to treat SMAS region 2216. Duringoperation, probe 2204 can also be mechanically and/or electronicallyscanned within tissue surface region 2226 to treat an extended area. Inaddition, spatial control of a treatment depth 2220 (or otherwisereferred to as depth) can be suitably adjusted in various ranges, suchas between a wide range of approximately 0 to 15 mm, suitably fixed to afew discrete depths, with an adjustment limited to a fine range, e.g.approximately between 3 mm to 9 mm, and/or dynamically adjusted duringtreatment, to treat SMAS layer 2216 that typically lies at a depthbetween approximately 5 mm to 7 mm. Before, during, and after thedelivery of ultrasound energy to SMAS region 2216, monitoring of thetreatment area and surrounding structures can be provided to plan andassess the results and/or provide feedback to control system 2202 and asystem user.

For example, in accordance with an embodiment, with additional referenceto FIG. 26D, ultrasound imaging of region 2222 can be used to monitortreatment by watching the amount of shrinkage of SMAS layer 2216 indirection of areas 2260 and 2262, such as in real time or quasi-realtime, during and after energy delivery to region 2220. The onset ofsubstantially immediate shrinkage of SMAS layer 2216 is detectable byultrasound imaging of region 2222 and may be further enhanced via imageand signal processing. In one embodiment, the monitoring of suchshrinkage can be advantageous because it can confirm the intendedtherapeutic goal of noninvasive lifting and tissue tightening; inaddition, such monitoring may be used for system feedback. In additionto image monitoring, additional treatment parameters that can besuitably monitored in accordance with various other embodiments mayinclude temperature, video, profilometry, strain imaging and/or gaugesor any other suitable spatial, temporal and/or other tissue parameters,or combinations thereof.

For example, in accordance with an embodiment of the present invention,with additional reference to FIG. 26E, an embodiment of a monitoringmethod and system 2200 may suitably monitor the temperature profile orother tissue parameters of the region of interest 2206, such asattenuation or speed of sound of treatment region 2222 and suitablyadjust the spatial and/or temporal characteristics and energy levels ofultrasound therapy transducer probe 2204. The results of such monitoringtechniques may be indicated on display 2208 in various manners, such as,for example, by way of one-, two-, or three-dimensional images ofmonitoring results 2270, or may comprise an indicator 2272, such as asuccess, fail and/or completed/done type of indication, or combinationsthereof.

In accordance with another embodiment, with reference to FIG. 26F, thetargeting of particular region 2220 within SMAS layer 2216 can besuitably be expanded within region of interest 2206 to include acombination of tissues, such as skin 2210, dermis 2212 2210, fat/adiposetissue 2214 2210, SMAS/muscular fascia/and/or other suspensory tissue2216 2210, and muscle 2218 2210. Treatment of a combination of suchtissues and/or fascia may be treated including at least one of SMASlayer 2216 or other layers of muscular fascia in combination with atleast one of muscle tissue, adipose tissue, SMAS and/or other muscularfascia, skin, and dermis, can be suitably achieved by treatment system2200. For example, treatment of SMAS layer 2216 may be performed incombination with treatment of dermis 2280 by suitable adjustment of thespatial and temporal parameters of probe 2204 within treatment system2200.

In accordance with various aspects of the present invention, atherapeutic treatment method and system for controlled thermal injury ofhuman superficial tissue to effectuate face lifts, deep tissuetightening, and other procedures is based on the ability to controllablycreate thermal lesions of conformally variable shape, size, and depththrough precise spatial and temporal control of acoustic energydeposition. With reference to FIG. 25 , in accordance with anembodiment, a therapeutic treatment system 2200 includes a controlsystem 2102 and a probe system 2104 that can facilitate treatmentplanning, controlling and/or delivering of acoustic energy, and/ormonitoring of treatment conditions to a region of interest 2106.Region-of-interest 2106 is configured within the human superficialtissue comprising from just below the tissue outer surface toapproximately 30 mm or more in depth.

Therapeutic treatment system 2100 is configured with the ability tocontrollably produce conformal lesions of thermal injury in superficialhuman tissue within region of interest 2106 through precise spatial andtemporal control of acoustic energy deposition, i.e., control of probe2104 is confined within selected time and space parameters, with suchcontrol being independent of the tissue. In accordance with anembodiment, control system 2102 and probe system 2104 can be suitablyconfigured for spatial control of the acoustic energy by controlling themanner of distribution of the acoustical energy. For example, spatialcontrol may be realized through selection of the type of one or moretransducer configurations insonifying region of interest 2106, selectionof the placement and location of probe system 2104 for delivery ofacoustical energy relative to region-of-interest 2106, e.g., probesystem 2104 being configured for scanning over part or whole ofregion-of-interest 2106 to produce contiguous thermal injury having aparticular orientation or otherwise change in distance fromregion-of-interest 2106, and/or control of other environment parameters,e.g., the temperature at the acoustic coupling interface can becontrolled, and/or the coupling of probe 2104 to human tissue. Inaddition to the spatial control parameters, control system 2102 andprobe system 2104 can also be configured for temporal control, such asthrough adjustment and optimization of drive amplitude levels,frequency/waveform selections, e.g., the types of pulses, bursts orcontinuous waveforms, and timing sequences and other energy drivecharacteristics to control thermal ablation of tissue. The spatialand/or temporal control can also be facilitated through open-loop andclosed-loop feedback arrangements, such as through the monitoring ofvarious spatial and temporal characteristics. As a result, control ofacoustical energy within six degrees of freedom, e.g., spatially withinthe X, Y and Z domain, as well as the axis of rotation within the XY, YZand XZ domains, can be suitably achieved to generate conformal lesionsof variable shape, size and orientation.

For example, through such spatial and/or temporal control, an embodimentof a treatment system 2100 can enable the regions of thermal injury topossess arbitrary shape and size and allow the tissue to be destroyed(ablated) in a controlled manner. With reference to FIG. 38 , one ormore thermal lesions may be created within a tissue region of interest3400, with such thermal lesions having a narrow or wide lateral extent,long or short axial length, and/or deep or shallow placement, includingup to a tissue outer surface 3403. For example, cigar shaped lesions maybe produced in a vertical disposition 3404 and/or horizontal disposition3406. In addition, raindrop-shaped lesions 3408, flat planar lesions3410, round lesions 3412 and/or other v-shaped/ellipsoidal lesions 3414may be formed, among others. For example, mushroom-shaped lesion 3420may be provided, such as through initial generation of a an initialround or cigar-shaped lesion 3422, with continued application ofablative ultrasound resulting in thermal expansion to further generate agrowing lesion 3424, such thermal expansion being continued untilraindrop-shaped lesion 3420 is achieved. The plurality of shapes canalso be configured in various sizes and orientations, e.g., lesions 3408could be rotationally oriented clockwise or counterclockwise at anydesired angle, or made larger or smaller as selected, all depending onspatial and/or temporal control. Moreover, separate islands ofdestruction, i.e., multiple lesions separated throughout the tissueregion, may also be created over part of or the whole portion withintissue region-of-interest 3400. In addition, contiguous structuresand/or overlapping structures 3416 may be provided from the controlledconfiguration of discrete lesions. For example, a series of one or morecrossed-lesions 3418 can be generated along a tissue region tofacilitate various types of treatment methods.

The specific configurations of controlled thermal injury are selected toachieve the desired tissue and therapeutic effect(s). For example, anytissue effect can be realized, including but not limited to thermal andnon-thermal streaming, cavitational, hydrodynamic, ablative, hemostatic,diathermic, and/or resonance-induced tissue effects. Such effects can besuitably realized at treatment depths over a range of approximately0-30000 μm within region of interest 2200 to provide a high degree ofutility.

An embodiment of a control system 2202 and display system 2208 may beconfigured in various manners for controlling probe and systemfunctionality. With reference again to FIGS. 27A and 27B, in accordancewith embodiments, a control system 2300 can be configured forcoordination and control of the entire therapeutic treatment process fornoninvasive face lifts and deep tissue tightening. For example, controlsystem 2300 can suitably comprise power source components 2302, sensingand monitoring components 2304, cooling and coupling controls 2306,and/or processing and control logic components 2308. Control system 2300can be configured and optimized in a variety of ways with more or lesssubsystems and components to implement the therapeutic system forcontrolled thermal injury, and the embodiments in FIGS. 27A and 27B aremerely for illustration purposes.

For example, for power sourcing components 2302, control system 2300 cancomprise one or more direct current (DC) power supplies 2303 configuredto provide electrical energy for entire control system 2300, includingpower required by a transducer electronic amplifier/driver 2312. A DCcurrent sense device 2305 can also be provided to confirm the level ofpower going into amplifiers/drivers 2312 for safety and monitoringpurposes.

Amplifiers/drivers 2312 can comprise multi-channel or single channelpower amplifiers and/or drivers. In accordance with an embodiment fortransducer array configurations, amplifiers/drivers 2312 can also beconfigured with a beamformer to facilitate array focusing. An embodimentof a beamformer can be electrically excited by an oscillator/digitallycontrolled waveform synthesizer 2310 with related switching logic.

The power sourcing components can also include various filteringconfigurations 2314. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 2312 to increasethe drive efficiency and effectiveness. Power detection components 2316may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 2316may be used to monitor the amount of power going to an embodiment of aprobe system.

Various sensing and monitoring components 2304 may also be suitablyimplemented within control system 2300. For example, in accordance withan embodiment, monitoring, sensing and interface control components 2324may be configured to operate with various motion detection systemsimplemented within transducer probe 2204 to receive and processinformation such as acoustic or other spatial and temporal informationfrom a region of interest. Sensing and monitoring components can alsoinclude various controls, interfacing and switches 2309 and/or powerdetectors 2316. Such sensing and monitoring components 2304 canfacilitate open-loop and/or closed-loop feedback systems withintreatment system 2200.

Still further, monitoring, sensing and interface control components 2324may comprise imaging systems configured for one-dimensional,two-dimensional and/or three dimensional imaging functions. Such imagingsystems can comprise any imaging modality based on at least one ofphotography and other visual optical methods, magnetic resonance imaging(MRI), computed tomography (CT), optical coherence tomography (OCT),electromagnetic, microwave, or radio frequency (RF) methods, positronemission tomography (PET), infrared, ultrasound, acoustic, or any othersuitable method of visualization, localization, or monitoring of aregion-of-interest 2106. Still further, various other tissue parametermonitoring components, such as temperature measuring devices andcomponents, can be configured within monitoring, sensing and interfacecontrol components 2324, such monitoring devices comprising any modalitynow known or hereinafter devised.

Cooling/coupling control systems 2306 may be provided to remove wasteheat from an embodiment of a probe 2204, provide a controlledtemperature at the superficial tissue interface and deeper into tissue,and/or provide acoustic coupling from transducer probe 2204 toregion-of-interest 2206. Such cooling/coupling control systems 2306 canalso be configured to operate in both open-loop and/or closed-loopfeedback arrangements with various coupling and feedback components.

Processing and control logic components 2308 can comprise various systemprocessors and digital control logic 2307, such as one or more ofmicrocontrollers, microprocessors, field-programmable gate arrays(FPGAs), computer boards, and associated components, including firmwareand control software 2326, which interfaces to user controls andinterfacing circuits as well as input/output circuits and systems forcommunications, displays, interfacing, storage, documentation, and otheruseful functions. System software and firmware 2326 controls allinitialization, timing, level setting, monitoring, safety monitoring,and all other system functions required to accomplish user-definedtreatment objectives. Further, various control switches 2308 can also besuitably configured to control operation.

An embodiment of a transducer probe 2204 can also be configured invarious manners and comprise a number of reusable and/or disposablecomponents and parts in various embodiments to facilitate its operation.For example, transducer probe 2204 can be configured within any type oftransducer probe housing or arrangement for facilitating the coupling oftransducer to a tissue interface, with such housing comprising variousshapes, contours and configurations. Transducer probe 2204 can compriseany type of matching, such as for example, electric matching, which maybe electrically switchable; multiplexer circuits and/or aperture/elementselection circuits; and/or probe identification devices, to certifyprobe handle, electric matching, transducer usage history andcalibration, such as one or more serial EEPROM (memories). Transducerprobe 2204 may also comprise cables and connectors; motion mechanisms,motion sensors and encoders; thermal monitoring sensors; and/or usercontrol and status related switches, and indicators such as LEDs. Forexample, a motion mechanism in probe 2204 may be used to controllablycreate multiple lesions, or sensing of probe motion itself may be usedto controllably create multiple lesions and/or stop creation of lesions,e.g. for safety reasons if probe 2204 is suddenly jerked or is dropped.In addition, an external motion encoder arm may be used to hold theprobe during use, whereby the spatial position and attitude of probe2104 is sent to the control system to help controllably create lesions.Furthermore, other sensing functionality such as profilometers or otherimaging modalities may be integrated into the probe in accordance withvarious embodiments. Moreover, the therapy contemplated herein can alsobe produced, for example, by transducers disclosed in U.S. applicationSer. No. 10/944,499, filed on Sep. 16, 2004, entitled Method And SystemFor Ultrasound Treatment With A Multi-Directional Transducer and U.S.application Ser. No. 10/944,500, filed on Sep. 16, 2004, and entitledSystem And Method For Variable Depth Ultrasound Treatment, both herebyincorporated by reference.

With reference to FIGS. 28A and 28B, in accordance with an embodiment, atransducer probe 2400 can comprise a control interface 2402, atransducer 2404, coupling components 2406, and monitoring/sensingcomponents 2408, and/or motion mechanism 2410. However, transducer probe2400 can be configured and optimized in a variety of ways with more orless parts and components to provide ultrasound energy for controlledthermal injury, and the embodiment in FIGS. 28A and 28B are merely forillustration purposes. Transducer 2404 can be any transducer configuredto produce conformal lesions of thermal injury in superficial humantissue within a region of interest through precise spatial and temporalcontrol of acoustic energy deposition.

Control interface 2402 is configured for interfacing with control system2300 to facilitate control of transducer probe 2400. Control interfacecomponents 2402 can comprise multiplexer/aperture select 2424,switchable electric matching networks 2426, serial EEPROMs and/or otherprocessing components and matching and probe usage information 2430 andinterface connectors 2432.

Coupling components 2406 can comprise various devices to facilitatecoupling of transducer probe 2400 to a region of interest. For example,coupling components 2406 can comprise cooling and acoustic couplingsystem 2420 configured for acoustic coupling of ultrasound energy andsignals. Acoustic cooling/coupling system 2420 with possible connectionssuch as manifolds may be utilized to couple sound into theregion-of-interest, control temperature at the interface and deeper intotissue, provide liquid-filled lens focusing, and/or to remove transducerwaste heat. Coupling system 2420 may facilitate such coupling throughuse of various coupling mediums, including air and other gases, waterand other fluids, gels, solids, and/or any combination thereof, or anyother medium that allows for signals to be transmitted betweentransducer active elements 2412 and a region of interest. In addition toproviding a coupling function, in accordance with an embodiment,coupling system 2420 can also be configured for providing temperaturecontrol during the treatment application. For example, coupling system2420 can be configured for controlled cooling of an interface surface orregion between transducer probe 2400 and a region of interest and beyondby suitably controlling the temperature of the coupling medium. Thesuitable temperature for such coupling medium can be achieved in variousmanners, and utilize various feedback systems, such as thermocouples,thermistors or any other device or system configured for temperaturemeasurement of a coupling medium. Such controlled cooling can beconfigured to further facilitate spatial and/or thermal energy controlof transducer probe 2400.

In accordance with an embodiment, with additional reference to FIG. 35 ,acoustic coupling and cooling 3140 can be provided to acousticallycouple energy and imaging signals from transducer probe 3104 to and fromthe region of interest 3106, to provide thermal control at the probe toregion-of-interest interface 3110 and deeper into tissue, and to removepotential waste heat from the transducer probe at region 3144.Temperature monitoring can be provided at the coupling interface via athermal sensor 3146 to provide a mechanism of temperature measurement3148 and control via control system 3102 and a thermal control system3142. Thermal control may consist of passive cooling such as via heatsinks or natural conduction and convection or via active cooling such aswith peltier thermoelectric coolers, refrigerants, or fluid-basedsystems comprised of pump, fluid reservoir, bubble detection, flowsensor, flow channels/tubing 3144 and thermal control 3142.

With continued reference to FIGS. 28A-28B, monitoring and sensingcomponents 2408 can comprise various motion and/or position sensors2416, temperature monitoring sensors 2418, user control and feedbackswitches 2414 and other like components for facilitating control bycontrol system 2300, e.g., to facilitate spatial and/or temporal controlthrough open-loop and closed-loop feedback arrangements that monitorvarious spatial and temporal characteristics.

Motion mechanism 2410 (or otherwise referred to as a movement mechanism)can comprise manual operation, mechanical arrangements, or somecombination thereof. For example, a motion mechanism 2422 can besuitably controlled by control system 2300, such as through the use ofaccelerometers, encoders or other position/orientation devices 2416 todetermine and enable movement and positions of transducer probe 2400.Linear, rotational or variable movement can be facilitated, e.g., thosedepending on the treatment application and tissue contour surface.

Transducer 2404 can comprise one or more transducers configured fortreating of SMAS layers and targeted regions. Transducer 2404 can alsocomprise one or more transduction elements and/or lenses 2412. Thetransduction elements can comprise a piezoelectrically active material,such as lead zirconante titanate (PZT), or any other piezoelectricallyactive material, such as a piezoelectric ceramic, crystal, plastic,and/or composite materials, as well as lithium niobate, lead titanate,barium titanate, and/or lead metaniobate. In addition to, or instead of,a piezoelectrically active material, transducer 2404 can comprise anyother materials configured for generating radiation and/or acousticalenergy. Transducer 2404 can also comprise one or more matching layersconfigured along with the transduction element such as coupled to thepiezoelectrically active material. Acoustic matching layers and/ordamping may be employed as necessary to achieve the desiredelectroacoustic response.

In accordance with an embodiment, the thickness of the transductionelement of transducer 2404 can be configured to be uniform. That is, atransduction element 2412 can be configured to have a thickness that issubstantially the same throughout. In accordance with anotherembodiment, the thickness of a transduction element 2412 can also beconfigured to be variable. For example, transduction element(s) 2412 oftransducer 2404 can be configured to have a first thickness selected toprovide a center operating frequency of approximately 2 kHz to 75 MHz,such as for imaging applications. Transduction element 2412 can also beconfigured with a second thickness selected to provide a centeroperating frequency of approximately 2 to 400 MHz, and typically between4 MHz and 15 MHz for therapy application. Transducer 2404 can beconfigured as a single broadband transducer excited with at least two ormore frequencies to provide an adequate output for generating a desiredresponse. Transducer 2404 can also be configured as two or moreindividual transducers, wherein each transducer comprises one or moretransduction element. The thickness of the transduction elements can beconfigured to provide center-operating frequencies in a desiredtreatment range. For example, transducer 2404 can comprise a firsttransducer configured with a first transduction element having athickness corresponding to a center frequency range of approximately 1kHz to 3 MHz, and a second transducer configured with a secondtransduction element having a thickness corresponding to a centerfrequency of approximately 3 MHz to 100 MHz or more.

Transducer 2404 may be composed of one or more individual transducers inany combination of focused, planar, or unfocused single-element,multi-element, or array transducers, including 1-D, 2-D, and annulararrays; linear, curvilinear, sector, or spherical arrays; spherically,cylindrically, and/or electronically focused, defocused, and/or lensedsources. For example, with reference to an embodiment depicted in FIG.29 , transducer 2500 can be configured as an acoustic array tofacilitate phase focusing. That is, transducer 2500 can be configured asan array of electronic apertures that may be operated by a variety ofphases via variable electronic time delays. By the term “operated,” theelectronic apertures of transducer 2500 may be manipulated, driven,used, and/or configured to produce and/or deliver an energy beamcorresponding to the phase variation caused by the electronic timedelay. For example, these phase variations can be used to deliverdefocused beams, planar beams, and/or focused beams, each of which maybe used in combination to achieve different physiological effects in aregion of interest 2510. Transducer 2500 may additionally comprise anysoftware and/or other hardware for generating, producing and or drivinga phased aperture array with one or more electronic time delays.

Transducer 2500 can also be configured to provide focused treatment toone or more regions of interest using various frequencies. In order toprovide focused treatment, transducer 2500 can be configured with one ormore variable depth devices to facilitate treatment. For example,transducer 2500 may be configured with variable depth devices disclosedin U.S. patent application Ser. No. 10/944,500, entitled “System andMethod for Variable Depth Ultrasound”, filed on Sep. 16, 2004, having atleast one common inventor and a common Assignee as the presentapplication, and incorporated herein by reference. In addition,transducer 2500 can also be configured to treat one or more additionalROI 2510 through the enabling of sub-harmonics or pulse-echo imaging, asdisclosed in U.S. patent application Ser. No. 10/944,499, entitled“Method and System for Ultrasound Treatment with a Multi-directionalTransducer”, filed on Sep. 16, 2004, having at least one common inventorand a common Assignee as the present application, and also incorporatedherein by reference.

Moreover, any variety of mechanical lenses or variable focus lenses,e.g. liquid-filled lenses, may also be used to focus and or defocus thesound field. For example, with reference to embodiments depicted inFIGS. 30A and 30B, transducer 2600 may also be configured with anelectronic focusing array 2604 in combination with one or moretransduction elements 2606 to facilitate increased flexibility intreating ROI 2610 (or 65 as shown in FIGS. 12-14 ). Array 2604 may beconfigured in a manner similar to transducer 2502. That is, array 2604can be configured as an array of electronic apertures that may beoperated by a variety of phases via variable electronic time delays, forexample, T₁, T₂ . . . T_(j). By the term “operated,” the electronicapertures of array 2604 may be manipulated, driven, used, and/orconfigured to produce and/or deliver energy in a manner corresponding tothe phase variation caused by the electronic time delay. For example,these phase variations can be used to deliver defocused beams, planarbeams, and/or focused beams, each of which may be used in combination toachieve different physiological effects in ROI 2610.

Transduction elements 2606 may be configured to be concave, convex,and/or planar. For example, in an embodiment depicted in FIG. 30A,transduction elements 2606 are configured to be concave in order toprovide focused energy for treatment of ROI 2610. Additional embodimentsare disclosed in U.S. patent application Ser. No. 10/944,500, entitled“Variable Depth Transducer System and Method”, and again incorporatedherein by reference.

In another embodiment, depicted in FIG. 30B, transduction elements 2606can be configured to be substantially flat in order to providesubstantially uniform energy to ROI 2610. While FIGS. 30A and 30B depictembodiments with transduction elements 2604 configured as concave andsubstantially flat, respectively, transduction elements 2604 can beconfigured to be concave, convex, and/or substantially flat. Inaddition, transduction elements 2604 can be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element can be configured to beconcave, while a second transduction element can be configured to besubstantially flat.

With reference to FIGS. 32A and 32B, transducer 2404 can be configuredas single-element arrays, wherein a single-element 2802, e.g., atransduction element of various structures and materials, can beconfigured with a plurality of masks 2804, such masks comprisingceramic, metal or any other material or structure for masking oraltering energy distribution from element 2802, creating an array ofenergy distributions 2808. Masks 2804 can be coupled directly to element2802 or separated by a standoff 2806, such as any suitably solid orliquid material.

An embodiment of a transducer 2404 can also be configured as an annulararray to provide planar, focused and/or defocused acoustical energy. Forexample, with reference to FIGS. 34A and 34B, in accordance with anembodiment, an annular array 3000 can comprise a plurality of rings3012, 3014, 3016 to N. Rings 3012, 3014, 3016 to N can be mechanicallyand electrically isolated into a set of individual elements, and cancreate planar, focused, or defocused waves. For example, such waves canbe centered on-axis, such as by methods of adjusting correspondingtransmit and/or receive delays, τ1, τ2, τ3 . . . τN. An electronic focuscan be suitably moved along various depth positions, and can enablevariable strength or beam tightness, while an electronic defocus canhave varying amounts of defocusing. In accordance with an embodiment, alens and/or convex or concave shaped annular array 3000 can also beprovided to aid focusing or defocusing such that any time differentialdelays can be reduced. Movement of annular array 2800 in one, two orthree-dimensions, or along any path, such as through use of probesand/or any conventional robotic arm mechanisms, may be implemented toscan and/or treat a volume or any corresponding space within a region ofinterest.

Transducer 2404 can also be configured in other annular or non-arrayconfigurations for imaging/therapy functions. For example, withreference to FIGS. 34C-34F, a transducer can comprise an imaging element3012 configured with therapy element(s) 3014. Elements 3012 and 3014 cancomprise a single-transduction element, e.g., a combinedimaging/transducer element, or separate elements, can be electricallyisolated 3022 within the same transduction element or between separateimaging and therapy elements, and/or can comprise standoff 3024 or othermatching layers, or any combination thereof. For example, withparticular reference to FIG. 34F, a transducer can comprise an imagingelement 3012 having a surface 3028 configured for focusing, defocusingor planar energy distribution, with therapy elements 3014 including astepped-configuration lens configured for focusing, defocusing, orplanar energy distribution.

With a better understanding of the various transducer structures, andwith reference again to FIG. 38 , how the geometric configuration of thetransducer or transducers that contributes to the wide range oflesioning effects can be better understood. For example, cigar-shapedlesions 3404 and 3406 may be produced from a spherically focused source,and/or planar lesions 3410 from a flat source. Concave planar sourcesand arrays can produce a “V-shaped” or ellipsoidal lesion 3414.Electronic arrays, such as a linear array, can produce defocused,planar, or focused acoustic beams that may be employed to form a widevariety of additional lesion shapes at various depths. An array may beemployed alone or in conjunction with one or more planar or focusedtransducers. Such transducers and arrays in combination produce a verywide range of acoustic fields and their associated benefits. A fixedfocus and/or variable focus lens or lenses may be used to furtherincrease treatment flexibility. A convex-shaped lens, with acousticvelocity less than that of superficial tissue, may be utilized, such asa liquid-filled lens, gel-filled or solid gel lens, rubber or compositelens, with adequate power handling capacity; or a concave-shaped, lowprofile, lens may be utilized and composed of any material or compositewith velocity greater than that of tissue. While the structure oftransducer source and configuration can facilitate a particular shapedlesion as suggested above, such structures are not limited to thoseparticular shapes as the other spatial parameters, as well as thetemporal parameters, can facilitate additional shapes within anytransducer structure and source.

In accordance with various embodiments of the present invention,transducer 2404 may be configured to provide one, two and/orthree-dimensional treatment applications for focusing acoustic energy toone or more regions of interest. For example, as discussed above,transducer 2404 can be suitably diced to form a one-dimensional array,e.g., transducer 2602 comprising a single array of sub-transductionelements.

In accordance with another embodiment, transducer 2404 may be suitablydiced in two-dimensions to form a two-dimensional array. For example,with reference to FIG. 33 , an embodiment with two-dimensional array2900 can be suitably diced into a plurality of two-dimensional portions2902. Two-dimensional portions 2902 can be suitably configured to focuson the treatment region at a certain depth, and thus provide respectiveslices 2904, 2907 of the treatment region. As a result, thetwo-dimensional array 2900 can provide a two-dimensional slicing of theimage place of a treatment region, thus providing two-dimensionaltreatment.

In accordance with another embodiment, transducer 2404 may be suitablyconfigured to provide three-dimensional treatment. For example, toprovide-three dimensional treatment of a region of interest, withreference again to FIG. 23 , a three-dimensional system can comprise atransducer within probe 104 configured with an adaptive algorithm, suchas, for example, one utilizing three-dimensional graphic software,contained in a control system, such as control system 102. The adaptivealgorithm is suitably configured to receive two-dimensional imaging,temperature and/or treatment or other tissue parameter informationrelating to the region of interest, process the received information,and then provide corresponding three-dimensional imaging, temperatureand/or treatment information.

In accordance with an embodiment, with reference again to FIG. 33 , athree-dimensional system can comprise a two-dimensional array 2900configured with an adaptive algorithm to suitably receive 2904 slicesfrom different image planes of the treatment region, process thereceived information, and then provide volumetric information 2906,e.g., three-dimensional imaging, temperature and/or treatmentinformation. Moreover, after processing the received information withthe adaptive algorithm, the two-dimensional array 2900 may suitablyprovide therapeutic heating to the volumetric region 2906 as desired.

In accordance with other embodiments, rather than utilizing an adaptivealgorithm, such as three-dimensional software, to providethree-dimensional imaging and/or temperature information, athree-dimensional system can comprise a single transducer 2404configured within a probe arrangement to operate from various rotationaland/or translational positions relative to a target region.

To further illustrate the various structures for transducer 2404, withreference to FIG. 31 , ultrasound therapy transducer 2700 can beconfigured for a single focus, an array of foci, a locus of foci, a linefocus, and/or diffraction patterns. Transducer 2700 can also comprisesingle elements, multiple elements, annular arrays, one-, two-, orthree-dimensional arrays, broadband transducers, and/or combinationsthereof, with or without lenses, acoustic components, and mechanicaland/or electronic focusing. Transducers configured as sphericallyfocused single elements 2702, annular arrays 2704, annular arrays withdamped regions 2706, line focused single elements 2708, 1-D lineararrays 2710, 1-D curvilinear arrays in concave or convex form, with orwithout elevation focusing, 2-D arrays, and 3-D spatial arrangements oftransducers may be used to perform therapy and/or imaging and acousticmonitoring functions. For any transducer configuration, focusing and/ordefocusing may be in one plane or two planes via mechanical focus 2720,convex lens 2722, concave lens 2724, compound or multiple lenses 2726,planar form 2728, or stepped form, such as illustrated in FIG. 34F. Anytransducer or combination of transducers may be utilized for treatment.For example, an annular transducer may be used with an outer portiondedicated to therapy and the inner disk dedicated to broadband imagingwherein such imaging transducer and therapy transducer have differentacoustic lenses and design, such as illustrated in FIGS. 34C-34F.

Moreover, such transduction elements 2700 may comprise apiezoelectrically active material, such as lead zirconante titanate(PZT), or any other piezoelectrically active material, such as apiezoelectric ceramic, crystal, plastic, and/or composite materials, aswell as lithium niobate, lead titanate, barium titanate, and/or leadmetaniobate. Transduction elements 2700 may also comprise one or morematching layers configured along with the piezoelectrically activematerial. In addition to or instead of piezoelectrically activematerial, transduction elements 2700 can comprise any other materialsconfigured for generating radiation and/or acoustical energy. A means oftransferring energy to and from the transducer to the region of interestis provided.

In accordance with another embodiment, with reference to FIG. 36 , atreatment system 2200 can be configured with and/or combined withvarious auxiliary systems to provide additional functions. For example,an embodiment of a treatment system 3200 for treating a region ofinterest 3206 can comprise a control system 3202, a probe 3204, and adisplay 3208. Treatment system 3200 further comprises an auxiliaryimaging modality 3274 and/or auxiliary monitoring modality 3272 may bebased upon at least one of photography and other visual optical methods,magnetic resonance imaging (MRI), computed tomography (CT), opticalcoherence tomography (OCT), electromagnetic, microwave, or radiofrequency (RF) methods, positron emission tomography (PET), infrared,ultrasound, acoustic, or any other suitable method of visualization,localization, or monitoring of SMAS layers within region-of-interest3206, including imaging/monitoring enhancements. Such imaging/monitoringenhancement for ultrasound imaging via probe 3204 and control system3202 could comprise M-mode, persistence, filtering, color, Doppler, andharmonic imaging among others. Further, in several embodiments anultrasound treatment system 3270, as a primary source of treatment, maybe combined or substituted with another source of treatment 3276,including radio frequency (RF), intense pulsed light (IPL), laser,infrared laser, microwave, or any other suitable energy source.

In accordance with another embodiment, with reference to FIG. 37 ,treatment composed of imaging, monitoring, and/or therapy to a region ofinterest may be further aided, augmented, and/or delivered with passiveor active devices 3304 within the oral cavity. For example, if passiveor active device 3304 is a second transducer or acoustic reflectoracoustically coupled to the cheek lining it is possible to obtainthrough transmission, tomographic, or round-trip acoustic waves whichare useful for treatment monitoring, such as in measuring acoustic speedof sound and attenuation, which are temperature dependent; furthermoresuch a transducer could be used to treat and/or image. In addition anactive, passive, or active/passive object 3304 may be used to flattenthe skin, and/or may be used as an imaging grid, marker, or beacon, toaid determination of position. A passive or active device 3304 may alsobe used to aid cooling or temperature control. Natural air in the oralcavity may also be used as passive device 3304 whereby it may beutilized to as an acoustic reflector to aid thickness measurement andmonitoring function.

During operation of an embodiment of a treatment system, a lesionconfiguration of a selected size, shape, orientation is determined.Based on that lesion configuration, one or more spatial parameters areselected, along with suitable temporal parameters, the combination ofwhich yields the desired conformal lesion. Operation of the transducercan then be initiated to provide the conformal lesion or lesions. Openand/or closed-loop feedback systems can also be implemented to monitorthe spatial and/or temporal characteristics, and/or other tissueparameter monitoring, to further control the conformal lesions.

With reference to FIG. 39 , a collection of simulation results,illustrating thermal lesion growth over time are illustrated. Suchlesion growth was generated with a spherically focused, cylindricallyfocused, and planar (unfocused) source at a nominal source acousticpower level, W₀ and twice that level, 2 W₀, but any configurations oftransducer can be utilized as disclosed herein. The thermal contoursindicate where the tissue reached 65° C. for different times. Thecontour for the cylindrically focused source is along the short axis, orso-called elevation plane. The figure highlights the different shapes oflesions possible with different power levels and source geometries. Inaddition, with reference to FIG. 40 , a pair of lesioning and simulationresults is illustrated, showing chemically stained porcine tissuephotomicrographs adjacent to their simulation results. In addition, withreference to FIG. 41 , another pair of lesioning results is illustrated,showing chemically stained porcine tissue photomicrographs, highlightinga tadpole shaped lesion and a wedge shaped lesion.

In summary, adjustment of the acoustic field spatial distribution viatransducer type and distribution, such as size, element configuration,electronic or mechanical lenses, acoustic coupling and/or cooling,combined with adjustment of the temporal acoustic field, such as throughcontrol of transmit power level and timing, transmit frequency and/ordrive waveform can facilitate the achieving of controlled thermallesions of variable size, shape, and depths. Moreover, the restorativebiological responses of the human body can further cause the desiredeffects to the superficial human tissue.

The citation of references herein does not constitute admission thatthose references are prior art or have relevance to the patentability ofthe teachings disclosed herein. All references cited in the Descriptionsection of the specification are hereby incorporated by reference intheir entirety for all purposes. In the event that one or more of theincorporated references, literature, and similar materials differs fromor contradicts this application, including, but not limited to, definedterms, term usage, described techniques, or the like, this applicationcontrols.

Some embodiments and the examples described herein are examples and notintended to be limiting in describing the full scope of compositions andmethods of these invention. Equivalent changes, modifications andvariations of some embodiments, materials, compositions and methods canbe made within the scope of the present invention, with substantiallysimilar results.

What is claimed is:
 1. A method of lifting skin tissue, the methodcomprising: positioning an ultrasound probe on a skin surface, theultrasound probe comprising a housing and at least one piezoelectricultrasound therapy element, using the at least one piezoelectricultrasound therapy element to treat a region of interest under the skinsurface, the region of interest comprising a tissue comprising at leastone of the group consisting of: a muscle, a fascia, a dermis, a fattissue, and a superficial muscular aponeurosis system (SMAS) tissue;wherein the at least one piezoelectric ultrasound therapy element isconfigured for targeted delivery of ultrasound energy to form at leastone thermal treatment area with a temperature in a range of 60-90degrees Celsius to treat at least a portion of the tissue under the skinsurface to lift the skin surface, wherein positioning the ultrasoundprobe on the skin surface comprises positioning the portion of theultrasound probe on at least one of the group consisting of: a forehead,an eyelid, a nose, an ear, and a neck.
 2. The method of claim 1, whereinpositioning the ultrasound probe on the skin surface comprisespositioning the portion of the ultrasound probe on the forehead or theneck.
 3. The method of claim 1, wherein positioning the ultrasound probeon the skin surface comprises positioning the portion of the ultrasoundprobe on at least one of the group consisting of: a preauricular region,a frontal region, and a mandibular region of a face.
 4. The method ofclaim 1, wherein positioning the ultrasound probe on the skin surfacecomprises positioning the portion of the ultrasound probe on a wrinkle.5. The method of claim 1, wherein the treating of the region of interestresults in any one or more of the group consisting of: a brow lift, ablepharoplasty, and an otoplasty.
 6. The method of claim 1, furthercomprising: imaging the region of interest with an imaging element inthe ultrasound probe, wherein the imaging element is configured to imagewith an imaging frequency of between 2 kHz to 75 MHz and the at leastone piezoelectric ultrasound therapy element is configured to treat witha treatment frequency of between 4 MHz and 15 MHz, wherein the imagingelement and the at least one piezoelectric ultrasound therapy elementare combined in a dual-mode imaging/therapy transducer, and displayingthe region of interest on a display system in electric communicationwith the imaging element.
 7. The method of claim 1, wherein the at leastone piezoelectric ultrasound therapy element comprises a plurality ofpiezoelectric ultrasound therapy elements.
 8. The method of claim 1,wherein the ultrasound probe is configured to treat at a depth within arange of 1 mm to 5 mm from the skin surface.
 9. The method of claim 1,wherein the ultrasound probe is electronically coupled to at least oneof the group consisting of: a battery and a secure storage element. 10.A method of treating skin with therapeutic ultrasound energy,comprising: providing an ultrasound probe comprising a housing and atleast one piezoelectric ultrasound therapy element that emits ultrasoundenergy; coupling the ultrasound probe to a skin surface over a tissueregion comprising any of the group consisting of a dermis tissue, a fattissue, a muscle tissue, and a superficial muscular aponeurosis system(SMAS) tissue; and delivering therapeutic ultrasound energy to thetissue region of interest at a depth within a range of 0.5 mm to 5 mmbelow the skin surface, wherein the therapeutic ultrasound energythermally treats collagen in the tissue region with the ultrasoundenergy at a temperature range of 60-90 degrees Celsius at the depthunder the skin surface to treat the skin, wherein coupling theultrasound probe to the skin surface comprises acoustically coupling theultrasound probe to at least one of the group consisting of: a forehead,an eyelid, a nose, a cheek, an ear, a mouth, and a neck.
 11. The methodof claim 10, wherein coupling the ultrasound probe to the skin surfacecomprises acoustically coupling the ultrasound probe to the forehead,the cheek, or the neck.
 12. The method of claim 10, further comprisingcooling of a tissue region of the skin surface.
 13. The method of claim12, further comprising activating a motion mechanism to move the atleast one piezoelectric ultrasound therapy element to form a pluralityof thermal foci along a line in the tissue region to reduce skinsagging.
 14. The method of claim 10, further comprising imaging thetissue under the skin surface and displaying an image of the tissue on adisplay.
 15. The method of claim 10, wherein the therapeutic ultrasoundenergy thermally treats the tissue region resulting in any one or moreof the group consisting of: a brow lift, a blepharoplasty, and anotoplasty.
 16. A method of lifting skin with ultrasound energy,comprising: identifying a skin surface; providing an ultrasonic probethat emits ultrasound energy; acoustically coupling the ultrasonic probeto the skin surface, wherein the skin surface is selected from the groupconsisting of one or more of the following: a forehead, an eyelid, anose, a cheek, an ear, and a mouth, and a neck; and deliveringtherapeutic ultrasound energy at a temperature at a treatment depthwithin a range of 1 mm to 30 mm below the skin surface, wherein thetherapeutic ultrasound energy treats at least one of the groupconsisting of dermis, fascia, fat, muscle, and cartilage at thetreatment depth under the skin surface to lift the skin surface.
 17. Themethod of claim 16, wherein the temperature is in a range of 0-60° C.18. The method of claim 16, wherein the depth is in a range of 0 to 5mm.
 19. The method of claim 16, further comprising cooling of a tissueregion of the skin surface, wherein the ultrasonic probe comprises anarray of piezoelectric therapy elements.
 20. The method of claim 16,wherein delivering therapeutic ultrasound energy comprises deliveringultrasound energy from a single spherically focused piezoelectricultrasound therapy element in the ultrasonic probe, further comprisingactivating a motion mechanism to move the single spherically focusedpiezoelectric ultrasound therapy element to form a plurality of thermalfoci along a line in a tissue region to reduce skin sagging, and furthercomprising imaging the at least one of the group consisting of dermis,fascia, fat, muscle, and cartilage under the skin surface and displayingan image of the at least one of the group consisting of dermis, fascia,fat, muscle, and cartilage on a display.